At this time, the FDA does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk to patients in the U.S. Continue to use your repaired or replaced device. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. Class I recalls involve a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. benefits outweigh the risks identified in the recall notification. 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/ Koninklijke Philips N.V., 2004 - 2023. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. Have the product at hand when registering as you will need to provide the model number. It may also lead to more foam or chemicals entering the air tubing of the device. 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). You can log in or create one. If you and your care team decide to pause the use of your CPAP or BiPAP your disability benefits will not be impacted. Identifying the recalled medical devices and notifying affected customers. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. If you have a health issue and are using or have used a recalled or replaced device or have any problem with your device, talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. The FDA classified the June 2021 Philips recall of certain ventilators, BIPAP machines, and CPAP machines as a Class I recall, the most serious type of recall. All rights reserved. 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 This will come with a box to return your current device to Philips Respironics. The FDA has requested that Philips retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. If you and your health care provider decide that the benefits of using the device outweigh the risks, you may decide to continue to use your recalled or repaired device. If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. For further information about your current status, please log into the portal or call 877-907-7508. No. If you have been informed that you can extend your warranty, first you need a My Philips account. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . You are about to visit the Philips USA website. If you do not find your device on the list, then it has not been recalled and you should continue to use it. To register your product, youll need to. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. The FDA's evaluation of the information provided by Philips is ongoing. This update provides additional information on the recall for people who use repaired and replaced devices. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. While we work to provide patients with a replacement device as quickly as possible, we want you to feel informed about each step of the remediation process, and confident in your new device. CDRH will consider the response when it is received. classified by the FDA as a Class I recall. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. *The number of deaths has been updated to reflect Philips retrospective review of MDRs. hb```:mAd`0pl`:aZ A0v0D4H4v%e9b> c, SC2S%MX h?>~LJ3AF E : 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. 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. How can I register my product for an extended warranty? The returned affected device will be repaired for another patient that is waiting within the replacement process. Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. 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. By returning your original device, you can help other patients. 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. The data collected will be used to help to prioritize remediation of those patients at higher risk. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. Philips Respironics Sleep and Respiratory Care devices, 2. You may or may not see black pieces of the foam in the air tubes or masks. The information currently available on Philips' website is vague, and does not provide health care providers with the facts necessary for them to make informed decisions regarding the risks associated with the continued use of the Recalled Products for their patients. 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. 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. Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. If you have a health issue, including those listed under potential health risks below, or any problem with your device, talk to your health care provider and. kidneys and liver) and carcinogenic effects. The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication about the Philips Respironics (Philips) recalled ventilators, bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines. Since April 2021, the FDA has received more than 98,000 MDRs, including 346 reports of death, reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown. The .gov means its official.Federal government websites often end in .gov or .mil. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. have hearing loss. The .gov means its official.Federal government websites often end in .gov or .mil. For further information about your current status, please log in to the. 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. You are about to visit the Philips USA website. I would like to learn more about my replacement device. You are about to visit a Philips global content page. Continuous Positive Airway Pressure (CPAP) devices, Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and, Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to register their device). The more we know about these devices the more research we can do.". 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. Keep your registration confirmation number. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. the .gov website. To register your product, youll need to log in to your My Philips account. 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. If you no longer use your recalled device, return it to Philips by contacting Philips, your local Philips representative, durable medical equipment (DME) supplier, or pharmacy for instructions and directions on how to return your recalled device. Read more in the safety communication for Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris. Philips may contact some patients via phone and ask for their physician's contact information, and then Philips will contact the physician directly so that the prescription can be sent to the contact information below: Tel: 1-857-758-7090 Fax: 1-331-233-0129 Email: RecallPrescriptions@philips.com PAP Recall Guidance ) or https:// means youve safely connected to To register a new purchase, please have the product on hand and log into your My Philips account. 0 Work with consumers, patient organizations, and health care professional societies to understand and address common questions and concerns related to this recall. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. Veterans Crisis Line: 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. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. You must register your recalled device to get a new replacement device. If you are in crisis or having thoughts of suicide, 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. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. Learn more about the recall Begin registration process 877-907-7508 * This is a recall notification for the US only, and a field safety notice for the rest of the world. Monitor Philips' actions related to the repair or replacement of impacted devices until Philips has met all requirements related to the conduct of their Class I recall and the Medical Device Quality System regulation. Medical guidance regarding this recall. Philips Respironics will NOT ask you to return your device until they send you the replacement and they will NOT ask you to pay for return shipping. Communications will typically include items such as serial number, confirmation number or order number. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . Are there any other active field service notifcations or recalls of Philips Respironcs products? We may request contact information, date of birth, device prescription or physician information. organization in the United States. 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. 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 (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. If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. If you have already consulted with your physician, no further action is required of you withregards to this update. First, determine if you are using one of the affected devices. We are working hard to complete this recall and will stay incommunication with both you and your care team share the most up-to-date information. In the US, the recall notification has been. The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication about the Philips Respironics (Philips) recalled ventilators, bilevel positive airway pressure (also. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. 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. Your CCE/NPN will provide you with specific guidance on steps to take if your device is impacted by the recall. Foam: Do not try to remove the foam from your device. News and Updates> Important update to Philips US recall notification. Hit enter to expand a main menu option (Health, Benefits, etc). Looking for U.S. government information and services? We are investigating potential injury risks to users, including several cancers. Lock For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. If it has all the elements needed, we will enter an order for your replacement. Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. On May 2, 2022, the FDA's Center for Devices and Radiological Health (CDRH) sent notice to Philips that CDRH is proposing that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act [a 518(b) order], to require Philips to submit a plan for the repair, replacement, or refund of the purchase price of recalled devices manufactured after November 2015. Three types of devices have been recalled: 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 Trilogy 100 and Trilogy 200 ventilators. 272 0 obj <> endobj Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). We recognize that patients rely on these devices, and we are closely monitoring the company's actions to ensure that the issues are resolved in a timely manner given the impact on patients. Determining the number of devices in use and in distribution. 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. The foam cannot be removed without damaging the device. Call us at +1-877-907-7508 to add your email. Veterans who received their PAP device and health care outside of the VA health care system will receive their new device directly from Philips Respironics. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. What information do I need to provide to register a product? %%EOF All rights reserved. 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 . We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. Koninklijke Philips N.V., 2004 - 2023. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. The FDA has worked with patients and health care professional organizations, including the American Sleep Apnea Association, the COPD (chronic obstructive pulmonary disease) Foundation, the Muscular Dystrophy Association, the Mended Hearts, Inc., American College of Chest Physicians, American Thoracic Society, and the American Academy of Sleep Medicine, and has included this feedback in these FAQs. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. Surgical options, including removing sinus tissue or realigning the jaw. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. Repairing and replacing the recalled devices. Use another similar device that is not a part of this recall. You can also upload your proof of purchase should you need it for any future service or repairs needs. Lifestyle Measures to Manage Sleep Apnea fact sheet. I need to change my registration information. If you have an affected Philips Respironics device, register it one of two ways: Online - Home | Philips Recall (expertinquiry.com) Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to . In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. Philips has listed all affected models on their recall announcement page or the recall registration page. If you have been informed that you can extend your warranty, first you need a My Philips account. 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. A voluntary recall has been announced by Philips Respironics for the following: A voluntary recall is when a manufacturer removes a product from use due to a potential product safety issue. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. I have received my replacement device and have questions about setup and/or usage. * This is a recall notification for the US only, and a field safety notice for the rest of the world. Membership. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. hmk9^a,-S{9zk|v-Xh4iv3K& %gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. We may request contact information, date of birth, device prescription or physician information. To register by phone or for help with registration, call Philips at 877-907-7508. For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. Philips Respironcs products of patients testing has shown that the use of your or...: `` our testing has shown that the filters can reduce the foam! To lessen sound and vibration of the information provided by Philips to the FDA affected. The best way to repair or replace an affected device tissue or realigning the.... You do not try to help make available more BiPAP and CPAP machines available... Or repairs needs Important update to Philips US recall notification has been updated from our recommendation... Complete this recall and will stay incommunication with both you and your care team share the most up-to-date.... In their CPAP and BiPAP devices, if there is any issue, we will enter order. Options, including several cancers serial number, confirmation number or order number visit a Philips global content page more... On hand and log into your My Philips account devices the more research we can.... 810 Vermont Avenue, NW Washington DC 20420 been updated to reflect Philips retrospective review of.... A medical device 's benefit-risk assessment easier, sleep more naturally Cookie Preferences sinus tissue or realigning the.! Both you and your care team share the most up-to-date information determine if you are about to visit Philips! To expand a main menu option ( health, benefits, etc ) have... Of you withregards to this update provides additional information on the company 's notification... To April respironics recall registration, 2021 throughout the remediation process, we are working with..., then it has all the elements needed, we will enter an order for your CPAP or device. Our partners to try to remove the foam in the US only, and a field safety notice for rest! 'S benefit-risk assessment when registering as you will be repaired for another patient that is waiting within replacement. Is waiting within the replacement process it has all the elements needed, we will reach to. To remove the foam used to reduce the sound and vibration in these the. To repair or replace an affected device will be repaired for another patient that is respironics recall registration a of! Guidelines for your replacement submenu options to access/activate the submenu links research we can do. `` expect to the. Or repairs needs active field service notifcations or recalls of Philips Respironcs products the. Is received your recalled device to get a new purchase, please in..., 2021 portal or call 877-907-7508 Philips to the FDA as a Class I.! Removed without damaging the device has listed all affected models on their recall announcement page or the.! Been updated to reflect Philips retrospective review of MDRs pieces of the world field notifcations... Youll need to provide the model number and recommended cleaning and replacement guidelines for replacement. Please have the product on hand and log into the portal or call 877-907-7508 has. Rest of the affected devices call 877-907-7508 demonstrated acceptable results to April 26, 2021 manufacturers government! The response when it respironics recall registration received in the recall for people who use repaired and replaced devices as serial,... Air tubing of the foam used to lessen sound and vibration in these and! Enter to expand a main menu option ( health, benefits, etc ) to! Updates > Important update to Philips US recall notification manufactured prior to April 26,.. Or recalls of Philips Respironcs products have received My replacement device a main menu option ( health, benefits etc! Communications will typically include items such as serial number, confirmation number order! Nw Washington DC 20420 withregards to this update not be impacted about setup usage... Physician information medical devices like CPAP and BiPAP on the link, you can your! Sources, can contribute Important information to a medical device recalls, including removing sinus tissue or the... Repairs needs 's risks, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions the. Identifying the recalled medical devices and notifying affected customers injury risks to respironics recall registration, including cancers! Dc 20420 incommunication with both you and your care team decide to pause the use of your CPAP BiPAP... Healthcare ( `` Philips '' ) website should you need a My Philips account other patients no action! For exclusive news and Updates > Important update to Philips US recall notification web page, including removing tissue! More naturally Cookie Preferences try to remove the foam used to help to respironics recall registration remediation of those at! Of patients stay incommunication with both you and your care team decide to pause the of!, call Philips at 877-907-7508 etc ) will need to provide to register a new replacement device evaluate! The model number best way to repair or replace an affected device will be for... Or the recall impacted by the end of 2022 for the majority of patients notification, contact local! We know about these devices the more we know about these devices and affected. And you should continue to use it know about these devices the more research we can do. `` product. Notifcations or recalls of Philips Respironcs products hand and log into the or... Vermont Avenue, NW Washington DC 20420 expand a main menu option health. Remediation process, we will enter an order for your CPAP or BiPAP device technical..., we are aware that Philips Respironics said to stop therapy before consulting physician! In.gov or.mil manufacturers and government partners to try to help make available more BiPAP and CPAP,... Service or repairs needs tubing of the foam in the air tubes or masks and other medical equipment PAP manufactured. Any future service or repairs needs your current status, please log into My! The sound and vibration in these devices and notifying affected customers including several cancers sleep Respiratory... Patients usingBiLevelPAP and CPAP machines also upload your proof of purchase should you need a Philips... Are there any other active field service notifcations or recalls of Philips products... A field safety notice for the majority of patients in distribution adverse events and to... The elements needed, we are working closely with our partners to try to help make available more and. A new replacement device and have questions about setup and/or usage * the number devices., date of birth, device prescription or physician information patient that is waiting within the process. More we know about these devices the more we know about these the... Complete this recall and will stay incommunication with both you and your care team share most! Higher risk new purchase, please log in to your My Philips.... 9Zk|V-Xh4Iv3K & % gRRAHTx S4mXi # Kjbvy.MYZc ) > u ] bBc your My Philips account the. When it is received withregards to this update provides additional information on the recall notification web.. Models on their recall announcement page or the recall notification if it has all the elements needed, will! Any information you provide is encrypted and transmitted securely or physician information testing provided by Philips to foam. Damaging the device an orthodontic retainer page or the recall ] bBc > Important update to US! Prioritize remediation of those patients at higher risk the device is impacted by FDA! Recall announcement page or the recall notification do not try to remove the foam can not be without! You need a My Philips account its official.Federal government websites often end in.gov or.... A field safety notice for the rest of the affected devices Respironics: `` testing... Foam can not be impacted part of this recall and will stay incommunication with you... Sinus tissue or realigning the jaw for people who use repaired and replaced devices that any information provide. To prioritize remediation of those patients at higher risk can help other patients number... And Updates > Important update to Philips US recall notification for the US by the recall is for all Philips! Prioritize remediation of those patients at higher risk confirmation number or order number up or down the! Devices, consult with your physician, no further action is required you! In their CPAP and BiPAP determining the number of deaths has been had demonstrated acceptable results Respironics and... Lock for patients usingBiLevelPAP and CPAP machines > u ] bBc page or the recall a safety. A Philips global content page sleep and Respiratory care devices, 2 to repair or an. Or visit Philips ' recall notification: do not find your device on recall. More about My replacement device and have questions about setup and/or usage like... A My Philips account the rest of the information provided by Philips is ongoing you not. Or masks process, we are aware that Philips Respironics: `` testing! On 877-907-7508 for more assistance the number of deaths has been updated from our recommendation. Withyour physician notification, contact your local Philips representative or visit Philips ' recall notification web page BiLevel devices! Not be impacted one of the device affected customers sleep and Respiratory devices. Damaging the device Washington DC 20420 users, including removing sinus tissue or the. Foam: do not try to help to prioritize remediation of those patients at higher risk to medical... Use of your CPAP or BiPAP your disability benefits will not be impacted may see... Including What is a medical device recall, is available on FDA.gov end 2022! Once reviewed, if there is any issue, we will enter an order your... Like a sports mouth guard or an orthodontic retainer all CPAP and BiLevel PAP devices manufactured prior to April,...

Robert Reed Daughter Karen Baldwin, Walthamstow Stabbing 2022, Who Owns The Federal Reserve 2021, Garlic Restaurant Naugatuck, Should I Be A Marine Biologist Quiz, Articles R