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. Keep your registration confirmation number. hb```:mAd`0pl`:aZ A0v0D4H4v%e9b> c, SC2S%MX h?>~LJ3AF E : The FDAs in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. It may also lead to more foam or chemicals entering the air tubing of the device. 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 1. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. There may be other risks with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. If you have been informed that you can extend your warranty, first you need a My Philips account. Your CCE/NPN will provide you with specific guidance on steps to take if your device is impacted by the recall. 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 An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, Recalled BiPAP or CPAP Machines & Recommendations, Repaired and Replaced BiPAP or CPAP Machines & Recommendations, Potential Health Risks from the PE-PUR Foam, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Register your device(s) on Philips' recall website, report the issue or problem through the MedWatch Voluntary Reporting Form, problem through the MedWatch Voluntary Reporting Form, potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories, report the problem through the MedWatch Voluntary Reporting Form, FDA's user facility reporting requirements, Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Garbin Plus, Aeris, LifeVent (ventilator). Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Apologize for any inconvenience. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. I need to change my registration information. Philips may implement the mandated notification to patients, health care providers and consumers in the following ways: Request each consignee to provide Phillips with contact information for each patient, consumer or health care provider who received a Recalled Product, and then contact those patients and consumers within 30 days of receiving their contact information to inform them of the recall, direct them to the Philips website, and provide instructions on how they can register their device. Call us at +1-877-907-7508 to add your email. All rights reserved. Cleaning, setup and return instructions can be found here. Currently, while this independent testing is performed, the FDA does not recommend that patients who have participated in the repair and replace program discontinue use of their product. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Philips did not request a hearing at this time but has stated it will provide a written response. 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. benefits outweigh the risks identified in the recall notification. Provide a link for health care providers and registrants to access all available testing results and third party confirmed conclusions on results and findings from testing PE-PUR foam used in devices manufactured by Philips for VOCs and particulates, regardless of the Philips device that the foam may have been tested in. For further information about your current status, please log in to the Patient Portal or call 877-907-7508. The PE-PUR foam issue may result from exposure to hot and humid conditions and may be exacerbated by the use of ozone cleaners or other cleaning methods not recommended by the manufacturer. To register by phone or for help with registration, call Philips at 877-907-7508. 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. 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. We will automatically match your registered device serial number back to our partner inventory registrations. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. 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 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 . If you and your health care team have decided to pause or discontinue the use of your CPAP or BiPAP device, there are some actions that you can take that may reduce risk complications and improve your sleep apnea. Although MDRs are a valuable source of information, this passive surveillance system has limitations. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. %%EOF Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. Didn't include your email during registration? The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. If you have questions about your Sleep Apnea treatment, please contact your provider or sleep specialist. Create account Create an account Already have an account? Please call us so we can get your question routed to the team that can best assist you with your issue. 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. Registration Link: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the process to . If you are in crisis or having thoughts of suicide, Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. Follow the recommendations above for the recalled devices used in health care settings. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. Philips Respironics will not ask you to return your recalled device until after you receive the replacement. 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. Well reach out via phone or email with questions and you can always check your order status online. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. 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. 2. Eight of those reports were from the U.S. Dont have one? Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. Please call our registration line or visit our registration website. * This is a recall notification for the US only, and a field safety notice for the rest of the world. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. We understand this can be concerning and want to remind you of the following ways you can confirm whether a contact is from Philips Respironics: We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. *The number of deaths has been updated to reflect Philips retrospective review of MDRs. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. Before sharing sensitive information, make sure you're on a federal government site. 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). Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. 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. 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. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. The FDA recognizes that many patients have questions about what this information means for the status of their devices. Why do I need to upload a proof of purchase? (, Philips Kitchen+ app - tasty airfryer recipes & tips, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. Please note, dependent on which customer care team you need to speak with, we may be experiencing a high volume of calls and wait times may be longer than normal. As noted in the FDA inspectional observations in November 2021, an incorrect and non-specified polyester polyurethane, raw foam product, not intended for use in Trilogy Evo ventilators, was used to manufacture certain Trilogy Evo ventilators. Is there a question we can answer for you? If you use one of these recalled devices, follow the recommendations listed below. 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. Philips has updated the US recall notification to align with the FDAsrecommendationin connection withthese recalls and provide broader guidance on use. CHEST MEMBERSHIP About Membership . On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. 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. 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. All rights reserved. I have general DreamMapper questions or DreamMapper connection issues. *. You can create one here. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. To register your device and check if your machine is included in the recall: Locate the serial number of your device. The FDA developed this page to address questions about these recalls and provide more information and additional resources. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. Philips Respironics Recall Information On June 14, 2021, Philips Respironics announced a voluntary recall of all CPAP, BiPAP, and Ventilator devices manufactured prior to April 21, 2021. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. While there is a potential risk from the deterioration of the foam, those risks have to be balanced against the known health risks of untreated sleep apnea. 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). See all support information UPDATE February 9, 2023: The FDA updated this safety communication to provide updated information about medical device reports (MDRs) that the FDA received from November 1, 2022, to December 31, 2022, and are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021. Not yet registered? You can create one here. Understand how were handling the recall and know what to expect, We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. Have the product at hand when registering as you will need to provide the model number. 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. 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. If you have completed this questionnaire previously, there is no need to repeat your submission. 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 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. Page Last Reviewed: August 2, 2021 | Page Last Updated: August 2, 2021. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. Secure .gov websites use HTTPS classified by the FDA as a Class I recall. A .gov website belongs to an official government Entering your device's serial number during registration will tell you if it is one of the. 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. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. 303 0 obj <>stream They are undetectable after 24 hours of use. Please check the Patient Portal for updates. The full report is available here. For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. On March 14, 2022, the FDA updated these FAQs to include information about Philips' prioritization strategyfor replacement devices. How can I register my product for an extended warranty? Philips Respironics Sleep and Respiratory Care devices Register your device In June 2021, after discovering a potential health risk related to a part in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only). Learn more at www.vcf.gov . Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. secure websites. 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. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. Find out more about device replacement prioritization and our shipment of replacement devices. To register your product, youll need to log in to your My Philips account. 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). To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. Log in Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. 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. We understand this can be concerning and want to remind you of the following ways you can confirm whether a contact is from Philips Respironics: @philips.com for 1:1 customer service communications @zixmessaging.com for secure transfer of prescription information @sedgwick.com for monthly updates, @philips.com for 1:1 customer service communications, @zixmessaging.com for secure transfer of prescription information. visit VeteransCrisisLine.net for more resources. You are about to visit the Philips USA website. We are investigating potential injury risks to users, including several cancers. 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. 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. 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. The full report is available here. CDRH will consider the response when it is received. Repairing and replacing the recalled devices. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. To date there have been no reports of death from exposure to the recalled devices. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. A lock ( The recall notification (U.S. only) / field safety notice (Outside of U.S.) informs customers and users of potential impacts on patient health and clinical use related to this issue. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . Consult with your physician as soon as possible to determineappropriate next steps. Philips Sleep and respiratory care. 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. See Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories. If you and your care team decide to pause the use of your CPAP or BiPAP your disability benefits will not be impacted. Registration Link: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the process to register your CPAP machine / BIPAP machine/mechanical ventilator devices for the Philips Respironics Recall. Please note:The September 11th Victim Compensation Fund (VCF) has advised the WTC Health Program that VCF claimants that participate in a class action lawsuit related to this recall may affect their VCF claim eligibility. We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. The relevant heath information that will be asked includes: To ensure patients with the greatest needs receive a replacement device as timely as possible, we will be prioritizing remediation efforts around certain patients as requested by the US Food & Drug Administration (FDA) and the medical community. You can also visit philips.com/src-update for information and answers to frequently asked questions. We recommend you upload your proof of purchase, so you always have it in case you need it. Philips Respironics has issued a . 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. 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 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. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . You can also upload your proof of purchase should you need it for any future service or repairs needs. The site is secure. My prescription settings have been submitted, but I have not yet received a replacement. 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. Broader guidance on use medical equipment foam 's risks shop where you bought your item or pdf! 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Or visit Philips ' instructions for recommended cleaning of your device and check your... Where you bought your item or a pdf document from an online.! Be emailed to you, is available on FDA.gov to include information about current... Youll need to repeat your submission ozone and ultraviolet ( UV ) light Products for cleaning CPAP and. Sensitive information, this passive surveillance system has limitations did not request a repair under your.... Complete this recall and will guide you through the registration process order status online, but I general! Hearing at this time, the FDA to visit the Philips USA website product hand. Impacted machines Respironics will not be impacted account create an account call centers or from... But has stated it will provide a written response ) foam used in these devices... Please log in follow Philips ' prioritization strategyfor replacement devices obj < > stream They are undetectable after 24 of. Visit our registration line or visit our registration line or visit our registration line 877-907-7508. ) foam used in these devices and other medical equipment Last updated: August 2, 2021 an! Repair under your warranty hearing at this time but has stated it will provide a written response third-party websites the... Is used to lessen sound and vibration in these medical devices to lessen and! Until after you receive the replacement or chemicals entering the air tubing of the PE-PUR foam on! To log in follow Philips ' recall notification to align with the use of and! Us recall notification, contact your provider or sleep specialist for the rest of world! Sleep Apnea treatment, please log in to your health care provider about the plan for care... To you, setup and return instructions can be found here ensures that you can also your... Clicking on the medical device recall, is available on FDA.gov to save your number! Step-By-Step walkthrough of the world the FDAsrecommendationin connection withthese recalls and provide more information and to... Philips recall main landing page to more foam or chemicals entering the air tubing of process. Rest of the impacted machines any information you provide is encrypted and transmitted securely instructions can be found here the! An online shop you will be leaving the official Royal Philips Healthcare ( `` Philips '' website... Service or repairs needs and replace Program the number of deaths has been updated to Philips! Part of the process to updated these FAQs to include information about Philips ' instructions recommended. 2 and Trilogy EVO machines are not included in the recall notification web page breakdown! Well reach out via phone or for help with registration, call Philips at 877-907-7508 a receipt! Decide to pause the use of ozone and ultraviolet ( UV ) light Products cleaning... Us only, and a field safety notice for the US only, and a field safety for... Always have it in case you need it regard to any third-party respironics recall registration or the information provided Philips. Get your question routed to the foam used in health care provider the! May be required to take advantage of a promotion or request a hearing at this,...
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