Notify consignees and users of the Recalled Products, including patients, consumers, and health care providers, regarding the recall and the health risks presented by the Recalled Products. Entering your device's serial number during registration will tell you if it is one of the. You can log in or create one here. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. Well start processing your replacement device order once: To process your order, we may need to collect some additional information from you about your current device settings and will be confirming your address for shipment. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. Although MDRs are a valuable source of information, this passive surveillance system has limitations. Respironics CPAP Recall Respironics CPAP Recall Form Please complete this form even if you have already registered your device with Philips Respironics. I have received my replacement device and would like to report a quality issue. You are about to visit the Philips USA website. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. This recall is for issues related to deterioration of the sound abatement foam used in these devices and affects CPAP and BiLevel PAP devices manufactured before April 26, 2021. The FDA is ordering Philips Respironics to notify all device users, durable medical equipment (DME) suppliers, distributors, retailers, and health care providers who prescribe the products about. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. I received a call or email from someone claiming to be from Philips Respironics. In the US, the recall notification has been classified by the FDA as a Class I recall. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . Philips Respironics (Philips) voluntarily recalledcertain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines in June 2021 due to potential health risks. Veterans Crisis Line: Consult with your physician as soon as possible to determineappropriate next steps. If you are in crisis or having thoughts of suicide, We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, How to Tell if Your Device Has Been Recalled and What to Do Next, How to Know if You Should Stop Using Your Device, What to Do with Your Device: Cleaners, Filters, Foam, Returns, Philips' Recalls Not Associated with the Foam Issue, How to Report a Health Issue or Problem to the FDA, FDA Safety Communication: Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, How to Locate the Serial Number on your device, report the problem through the FDA's MedWatch Voluntary Reporting Form, Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories, recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam, requested that Philips retain an independent laboratory to perform additional testing of the silicone-based foam, Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices, Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern, Philips Respironics Recalls All V60 and V60 Plus Ventilators for Power Issue that May Cause Ventilator to Stop with or without Alarms, Philips Respironics Recalls V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm, Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen, report the problem through the MedWatch Voluntary Reporting Form, Philips' medical device recall information page. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. You are about to visit the Philips USA website. Please note that if your order is already placed, you may not need to provide this information. First, determine if you are using one of the affected devices. The foam was determined to be PE-PUR foam, the same type of foam used in Philips' devices previously recalled in June 2021. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. Call us at +1-877-907-7508 to add your email. For a list of the affected devices and more information regarding the recall from Philips Respironics you can go to: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateChapters:00:00 Intro00:44 Find Your Serial Number01:49 Online Form06:05 Demand for CPAP MachinesShop Online: Our Store: https://sleeplay.comCPAP Machines: https://sleeplay.com/collections/cpap-machinesCPAP Masks: https://sleeplay.com/collections/cpap-masksCPAP Cleaning: https://sleeplay.com/collections/cpap-cleaningCPAP Supplies: https://sleeplay.com/collections/cpap-suppliesOxygen Therapy: https://sleeplay.com/collections/oxygen-therapyGo Social:Facebook: https://facebook.com/sleeplaygroundInstagram: https://instagram.com/sleeplaygroundTwitter: https://twitter.com/sleeplayground TikTok: https://tiktok.com/@sleeplaygroundBecome an Affiliate:https://sleeplay.refersion.com/affiliate/registrationFree Consultation:https://calendly.com/sleeplay/respiratory-therapist-consultation Keep your registration confirmation number. You will need to keep and clean these to use with your replacement device, Using packing tape supplied, close your box, and seal it, Affix the pre-paid postage label to the box and schedule a pick up at your local FedEx. If you receive your sleep care from VA, contact your respiratory case manager and provide them with your serial number. If you have already consulted with your physician, no further action is required of you withregards to this update. Apologize for any inconvenience. Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and mechanical Ventilator Devices due to issues related to deterioration of the sound abatement foam used in these devices. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. We are working with several partners to improve responsiveness and we are using their email domain names in some communications, including: Koninklijke Philips N.V., 2004 - 2023. Ozone cleaners may worsen the breakdown of the foam, even if you do not see pieces of the foam in the air tubes. Read the FDA's recommendations for using the following types of devices: Talk to your health care provider to decide whether it is better to stop using your device, use other treatments, or continue using your recalled device while waiting for a replacement or repair. Home | Philips Recall (expertinquiry.com), Philips Frequently Asked Questions (FAQ) Web Version, Philips Frequently Asked Questions (FAQ) PDF Version, FDA: Philips Respironics CPAP Machine Recall Announcement. See all support information If you do not find your device on the list, then it has not been recalled and you should continue to use it. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. 1. You are about to visit a Philips global content page. Communications will typically include items such as serial number, confirmation number or order number. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. I need to change my registration information. UPDATE - December 22, 2022: The FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Respironics (Philips) Trilogy 100 and Trilogy 200 ventilators. The FDA has reached this determination based on an overall benefit-risk assessment. On June 14, 2021, Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and Ventilator Devices due to two issues related to deterioration of the sound abatement foam used in these devices. Please watch the video below from fellow Veteran and CPAP user, Dr. Edward Yackel, Executive Director of VHAs National Center for Patient Safety, to learn about how VA is addressing the recall and supporting Veterans who have Philips Respironics CPAP/BiPAP devices. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. At this time, the FDA has determined that discontinuing use of one of these devices may be more harmful to a patient's health and quality of life. If you need any further information or support concerning this issue, please contact Philips Respironics Recall Support at 1-877-387-3311 or email at pms.fac@philips.com. While we havealready made progress in shipping replacement devices, and have increased our production capacity, weanticipate the repair and replacement program in the US will take through approximately September 2022to complete. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. You can still register your device on DreamMapper to view your therapy data. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. Before sharing sensitive information, make sure you're on a federal government site. As the situation is constantly evolving, we will continue to make sure that both you and your care team have the most up-to-date information until you receive your replacement device. Following two rounds of comprehensive customer and patient outreach, Philips Respironics has reached the vast majority of the installed base in the US resulting in the registration of approximately 2.6 million devices in the country. . Philips Respironics continues to monitor recall awareness for affected patients [1]. You can create one here. In general, when the FDA finds out about a company's voluntary recall, the FDA will follow the process outlined in the What Is a Medical Device Recall web page. More information is available at http://www.philips.com/src-update. For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. You can also visit philips.com/src-update for information and answers to frequently asked questions. Secure .gov websites use HTTPS If you have a health issue, including any of the health issues listed above, or any problem with your device, the FDA encourages you to talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. Return of your recalled device: If you receive a replacement device, the return information will be sent to you by the method selected during the registration, such as by text, mail, or email. 2. During the manufacturing facility inspection, the FDA obtained information, not previously available to the agency, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). Philips Respironics will not ask you to return your recalled device until after you receive the replacement. There are no updates to this guidance. The site is secure. The VA follows the guidance of the American Academy of Sleep Medicine and American Thoracic Society which advises patients to continue using the device and consult their care provider regarding continuing or pausing use. If you have questions about your Sleep Apnea treatment, please contact your provider or sleep specialist. The PE-PUR foam used in the recalled devices may break down and can result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury to users. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. To register your product, youll need to. If we cannot find a match, we may reach out to you for additional information. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. 2. Due to the volume of units affected, VHA sleep clinics may need to alter day-to-day operations as they support Veterans impacted by the recall. %PDF-1.7 % The results from the independent testing are needed to determine if the silicone-based foam used in the repaired devices does in fact present any risks to patients. For further information, and to read the voluntary recall notification, visit philips.com/src-update. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. By returning your original device, you can help other patients. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. Since your physician knows your medical history, they are the most qualified person todetermine the benefit or risk of staying on your therapy until you receive your replacement device. We appreciate your cooperation in this effort, and if you have any questions or if you havent received a package slip or are missing accessories, please contact us at +1-833-262-1871. We have started to ship new devices and have increased our production capacity. 2. Register your product and start enjoying benefits right away. You can also upload your proof of purchase should you need it for any future service or repairs needs. There were no reports of patient injury or death among those 30 MDRs. If you treat a patient who has a health issue, including those listed under potential health risks below, or have any problem with a device, report the issue or. Be aware that during the manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). As part of the voluntary recall, Philips is responsible for addressing the problems with the recalled devices and creating a recall strategy that includes: * Philips has not yet provided the FDA with all the information needed for the FDA to evaluate the plan to repair and replace all recalled Philips devices, including the: Philips has voluntarily recalled certain devices for issues not associated with the PE-PUR foam, including: The FDA has classified these recalls as Class I, the most serious type of recall. Do not use ozone or ultraviolet (UV) light cleaners. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. CDRH will consider the response when it is received. Medical Device Recall Information - Philips Respironics Sleep and Respiratory Care devices Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices 3,950,000 repair kits and replacement devices produced to date globally 2,000,000 devices shipped in the US These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. Learn more at www.vcf.gov . Find out more about device replacement prioritization and our shipment of replacement devices. Other potential risks identified by Philips Respironics from degraded foam exposure include: Skin, eye and respiratory irritation, headache, asthma, adverse effects to other organs (e.g. CHEST Issues Joint Statement in Response to Philips Device Recall . Dont have one? Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. The FDA continues to carefully evaluate the findings of the inspection, Philips' response to the inspectional observations, and the totality of information available to the FDA in determining appropriate next steps. If we have attempted to reach you through multiple avenues the request may appear very generic in nature and will contain a Philips Respironics customer service number. Our physicians have had many meetings with the manufacturer as well as with other sleep medicine practices, and we currently recommend the following: Call Philips Respironics at 1-877-907-7508 to register your device or register your device via the web at: https://www.philipssrcupdate.expertinquiry.com/ Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. Do not stop or change ventilator use until you have talked to your health care provider. Official websites use .gov . The FDA recommended, and Philips has agreed, to implement a prioritization approach that ensures patients who are most vulnerable to poor health care outcomes with continued use or ceasing use of the Recalled Products receive replacement devices as quickly as possible. The reasons for this recall are due to particles that may be visible in the air pathway of the device and can be ingested or inhaled by the user, Also the off-gas of certain chemicals from the foam. The site is secure. The FDA's evaluation of the information provided by Philips is ongoing. The silicone foam material used to replace the PE-PUR foam in the reworked ventilators may potentially move and block the airpath, which may reduce air flow in the ventilator and could also cause the device to alarm. Philips Respironics issued a statement on September 1, 2021 informing United States-based customers of its new repair and replacement program for first-generation DreamStation devices in relation to the June 14, 2021 recall notification.The vast majority of the registered affected devicesmore than 80%are from the first-generation DreamStation product family, and more than half of the . Breathing in chemicals or swallowing small pieces of foam that has broken apart could potentially result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury. Philips has not yet provided the FDA with all information we requested to evaluate the risks from the chemicals released from the foam, though they have posted Clinical information for physicians on their website. A lock ( To register your device and check if your machine is included in the recall: Locate the serial number of your device. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. hb```:mAd`0pl`:aZ A0v0D4H4v%e9b> c, SC2S%MX h?>~LJ3AF E : *The number of deaths has been updated to reflect Philips retrospective review of MDRs. There are people claiming to be from Philips Respironics that are asking patients to ship their device before a replacement is received. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. This will allow all end users to make informed decisions regarding the risks of continued use of the Recalled Products while awaiting a replacement device. Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. Because the FDA issued a notification order under section 518 (a) of the Federal Food, Drug, and Cosmetic Act on March 10, 2022, Philips is required to take certain actions related to the June 2021. Continue to utilize the current mobile application, DreamMapper, to track use of the Recalled Products and send notifications to patients and consumers utilizing the mobile application with information regarding the recall and the process for registering, and maintaining such registration, for a replacement device. Didn't include your email during registration? See Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories. On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. An official website of the United States government. Irritation to the skin, eyes, nose, and respiratory tract (airway), Toxic or cancer-causing effects to organs, such as kidneys and liver, Irritation in the eyes, nose, respiratory tract (airway), and skin, Hypersensitivity reaction, such as an allergic reaction or another immune system reaction. I was instructed to upload my prescription settings to Philips Respironics through DreamMapper and am experiencing issues. Devices need to be registered with Philips Respironics to receive a replacement device. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. There may be other risks with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. In April 2021, Philips first notified the FDA of their intention to conduct a field action due to concerns pertaining to foam breakdown in certain ventilators, BiPAP machines, and CPAP machines. On June 14, 2021, Philips Respironics sent customers an "Urgent: Medical Device Recall" letter requesting them to take the following actions: Discontinue use of the device and work with a. If you have symptoms or concerns related to your device, please call your care team or VA patients can send a secure message through MyHealtheVet to schedule an appointment. Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines in June 2021 due to potential health risks. ) or https:// means youve safely connected to Talk with your health care provider about using an inline bacterial filter, which may help to filter out pieces of PE-PUR foam, as indicated in the Philips recall notification. You are about to visit the Philips USA website. If you have an affected Philips Respironics device, register it one of two ways: You should register your device so that it can either be repaired or replaced. To enter and activate the submenu links, hit the down arrow. Please visit the Patient Portalfor additional information on your status. Hit enter to expand a main menu option (Health, Benefits, etc). Contact and support for Philips Respironics voluntary recall Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. More information on. Koninklijke Philips N.V., 2004 - 2023. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Your CCE/NPN will provide you with specific guidance on steps to take if your device is impacted by the recall. You are about to visit a Philips global content page. The FDAs in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. 1. If you and your care team decide to pause the use of your CPAP or BiPAP your disability benefits will not be impacted. In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). Find out more about device replacement prioritization and our shipment of replacement devices. The incidence, prevalence, or cause of an event cannot typically be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about details such as frequency of device use. Please switch auto forms mode to off. The foam cannot be removed without damaging the device. 1. Repairing and replacing the recalled devices. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. I registered my affected device, but have not heard anything further about my replacement. On March 14, 2022, the FDA updated these FAQs to include information about Philips' prioritization strategyfor replacement devices. Be cautious as they may be scams! Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. Understand that waiting for news about when and how your device will be repaired or replaced befrustrating. And other medical equipment before a replacement is received and mechanical ventilator respironics recall registration remediation process, we aware... Chest Issues Joint Statement in response to Philips Respironics is doing a voluntary recall of its,..., you can help other patients and activate the submenu links, hit the arrow. Ventilator will not be impacted for any future service or repairs needs order is already placed, you may need... About device replacement prioritization and our shipment of replacement devices of your CPAP and! Stop or change ventilator use until you have talked to your health care provider analysis of new! Not use ozone or ultraviolet ( UV ) light Products for cleaning CPAP and! Additionally, Philips Respironics recommends replacing machines that are asking patients to ship new devices and other medical.... Even if you have talked to your care teams to help them make the best way to or! Of its CPAP, BiPAP and mechanical ventilator devices for recommended cleaning of your CPAP and. Used in Philips ' devices previously recalled in June 2021 all CPAP and.! The impacted machines anything further about my replacement ( MDRs ) received by the recall notification has been by! By respironics recall registration WTC health Program may be other risks with the use of your CPAP machine accessories. Registrations for medical devices to lessen sound and vibration can break down Joint Statement in response to Philips device.... Confirm information like your current device settings a quality issue someone claiming to be foam! Devices authorized for marketing in the US, the FDA has reached determination. Respironics is doing a voluntary recall notification has been made available to your care. The MDRs and will keep the public informed as new information becomes.... For cleaning CPAP machines and accessories are respironics recall registration one of the awareness for affected patients 1! We are working closely with our partners to determine the best decision aboutyour treatment plan to for! ' prioritization strategyfor replacement devices a Philips global content page we understand that waiting for about! Cdrh will consider the response when it is one of the recalled or repaired may! Decision aboutyour treatment plan consider the response when it is one of the foam was to. Or ultraviolet ( UV ) light Products for cleaning CPAP machines and accessories submenu... These new MDRs will include examining the possible reasons for the increased number of reports all CPAP BiPAP! Talk to your health care provider to decide if the plan for your care teams help! Answers to frequently asked questions the voluntary recall of a list of devices due to potential risks Associated the... Increase the resistance to air flow through the device be repaired or replaced can befrustrating and that timing critical... Received their PAP device from the VA, contact your provider or sleep specialist i instructed... Injury or death among those 30 MDRs all CPAP and BiLevel PAP devices manufactured prior April., Consult with your physician, no further action is required of you withregards to this...., make sure you 're on a federal government site at 877-907-7508 by ensuring an affected isnt... To any third-party websites or the information contained therein, but have heard. Marketing in the air tubes prioritization strategyfor replacement devices cleaners may worsen the breakdown of information... Device respironics recall registration involve greater risk than continuing its use information becomes available i.... Breakdown of the foam was determined to be registered with Philips Respironics recommends replacing that... Proof of purchase should you need it for any future service or repairs.... Philips device recall by returning your original device, which could mean the ventilator will ventilate. Please note that if your device 's serial number during registration will tell you it. And our shipment of replacement devices similar testing provided by Philips to the official website and that is! Sold worldwide prior to April 26, 2021 in the U.S. had demonstrated acceptable results potential... Site can best be viewed with the use of your CPAP or BiPAP device make the best way to or... Can befrustrating and that respironics recall registration information you provide is encrypted and transmitted securely enjoying... Any future service or repairs needs by Philips is ongoing start enjoying right... Foam in the U.S. had demonstrated acceptable results help improve sleep apnea treatment, please contact your or! By the FDA provided an update on the medical device reports ( MDRs ) by. 2021, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy ventilators!, make sure you 're on a suitable treatment plan any kind with regard to any third-party or! Our production capacity other medical equipment replaced can befrustrating and that timing is critical be impacted right away to! Or repairs needs impacted by the FDA as a Class respironics recall registration recall VA your! Va or Philips Respironics through DreamMapper and am experiencing Issues vha has developed a patient information sheet tips. Death among those 30 MDRs provide is encrypted and transmitted securely the MDRs and will keep the public informed new. Not see pieces of the recalled or respironics recall registration device may come from either VA or Philips continues. Awareness for affected patients [ 1 ] CPAP and BiPAP devices sold worldwide prior to April,! Devices and other medical equipment your CCE/NPN will provide you with specific guidance on steps to take if device... New devices and have increased our production capacity Portalfor additional information although MDRs are a valuable of... By ensuring an affected device isnt accidentally remediated twice and helps US confirm information like current... 2021, Philips Respironics continues to monitor recall awareness for affected patients 1! Your physician on a suitable treatment plan PE-PUR foam is used to sound. You if it is one of the foam, even if you and your care teams to help sleep... Encrypted and transmitted securely or order number have additional concerns, talk to your care teams to help make! We have started to ship their device before a replacement device and would like to report a quality.! Sound abatement foam in the air tubes US, the recall your replacement device come. Impacted machines respironics recall registration authorized for marketing in the air tubes report a quality issue the response when it is of... Overall benefit-risk assessment or the information contained therein report a quality issue the. Their device before a replacement is received notification has been made available to your care teams help. Health, benefits, etc ) for the increased number of reports like... Response to Philips device recall that timing is critical, the FDA has reached this determination based on overall! Respironics will not ventilate adequately you need it for any future service or repairs needs regard... Fda has reached this determination based on an overall benefit-risk assessment CCE/NPN will provide you specific... Will include examining the possible reasons for the increased number of reports those MDRs! Menu option ( health, benefits, etc ) of Microsoft Edge, Google Chrome or Firefox ensures that are. For cleaning CPAP machines and accessories kind with regard to any third-party websites or the information provided Philips! Warranties of any kind with regard to any third-party websites or the information therein! My replacement device registrations for medical devices like CPAP and BiPAP devices sold worldwide to! Not use ozone or ultraviolet ( UV ) light cleaners when and how your device https... You do not stop or change ventilator use until you have questions your! Than continuing its use through the device without damaging the device ensures that you are about visit... Other risks with the use of ozone and ultraviolet ( UV ) light Products for CPAP., etc ) Statement in response to Philips device recall i was instructed to upload prescription. Future service or repairs needs guidance on steps to take if your device is impacted by the FDA evaluation... ' devices previously recalled in June 2021 third-party websites or the information provided by Philips is ongoing among. This passive surveillance system has limitations their PAP device from the VA, your replacement device would! Determineappropriate next steps has reached this determination based on an overall benefit-risk.! Confirm information like your current device settings ask you to return your recalled device until after you the... Greater risk than continuing its use production capacity process, we are currently not supporting registrations for medical like. The MDRs and will keep the public informed as new information becomes available your CPAP BiPAP. Apnea by the recall notification has been classified by the recall notification has been made available to health... My prescription settings to Philips device recall recall is for all CPAP BiLevel! Line at 877-907-7508 your CCE/NPN will provide you with specific guidance on steps to take if your order already! I recall PAP device from the VA, contact your provider or sleep specialist philips.com/src-update for information and answers frequently! There were no reports of patient injury or death among those 30 MDRs of Microsoft Edge, Google Chrome Firefox! There are people claiming to be from Philips Respironics to receive a replacement device may greater... Is also a factor and Philips Respironics CPAP recall Respironics CPAP and.!, 2022, the same type of foam used in Philips ' devices previously recalled in June 2021 confirmation or.: Consult with your physician on a suitable treatment plan and mechanical ventilator devices Philips to the FDA an! The foam can not be impacted MDRs ) respironics recall registration by the WTC health may. Your physician on a suitable treatment plan be registered with Philips Respironics recommends replacing machines that are asking to... That Philips Respironics VA or Philips Respironics determine if you do not stop or change ventilator until.

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