philips respironics recall registration

Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. The environmental conditions that may be one of the causes of this issue refer to the climate and regional temperatures of the countries where the devices are used and stored. Patient safety is our top priority, and we are committed to supporting ourpatients, durable medical equipment providers (DMEs), distributors, home healthpartners, and clinicians through the complete remediationprocess. However, this new recall does apply to some of the devices recalled . Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. As a result of extensive ongoing review, on June 14, 2021, Philips voluntarily decided to issue a global recall notification related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. 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. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. A-Series BiPAP V30 (Auto Ventilator) and OmniLab Advanced+ machines are used in clinical environments only. At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. 3. Philips is notifying regulatory agencies in the regions and countries where affected products are available. For patients using life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed ventilator therapy. The issues prompting the corrective action relate to the polyester-based polyurethane (PE-PUR) foam that is used in affected devices to reduce sound and vibration. Medical Device Recalls, Recalls, Market Withdrawals and Safety Alerts, Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern, Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, was corrected or replaced through the June 2021 recall, Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue, Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue: FDA Safety Communication, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, report adverse reactions or quality problems, Product Name: Philips Respironics BiPAP A30, A40, V30, and OmniLab Advanced+. What happens after I register my device, and what do I do with my old device? Patient safety is our top priority, and we are committed to supporting ourpatients, durable medical equipment providers (DMEs), distributors, home healthpartners, and clinicians through the complete remediationprocess. Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are typically recommended to be replaced after five years of use. The .gov means its official.Federal government websites often end in .gov or .mil. The issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). Talk with health care providers to decide if your care and treatment should change as a result of this recall. On Friday July 2 2021, following consultation with the Therapeutic Goods Administration (TGA) and Medsafe, Philips Australia and New Zealand announced it is conducting an Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand for the specific affected devices. Customers who need any further information or support should contact Philips Recall Support at 1-877-387-3311 or email at pms.fac@philips.com. Where do I direct questions about my replacement device? Affected devices currently will be either replaced with a new or refurbished unit that incorporates the new material, or repaired to replace the sound abatement foam in customer units. Has Philips received any reports of patient harm due to this issue? The return shipment for your old device is pre-paid so there is no charge to you. 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 - July 8, 2022, For more information on the recall notification for customers, users and physicians, please, You may also find the following articles interesting, For any other matters not directly related to Investor Relations, please visit our. Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are typically recommended to be replaced after five years of use. While the risks identified have resulted in Philips recommending discontinued use, it is important that you consult with your physician to determine the most appropriate options for continued treatment. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. What is the cause of this issue? By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Patients who are concerned should check to see if their device is affected by the corrective action. Membership & Community. 3. Images may vary. This factor does not refer to heat and humidity generated by the device for patient use. health outcomes, was observed for OLD among OSA patients between the users or polyurethane PAP and non-foam PAP - click here for more details. On June 14, 2021,Royal Philips subsidiary, Philips Respironics, initiated a voluntary recall notification* for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. Do not stop or alter your prescribed ventilator therapy. Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. Products not affected by thisrecall notification (U.S. only) / field safety notice (International Markets) include: All oxygen concentrators, respiratory drug delivery products, airway clearance products. BiPAP machines may be used to treat adult and pediatric patients at home and in clinical environments, such as hospitals and sleep laboratories, depending on the instructions for use for the particular device model. If you do not have this letter, please call the number below. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. As of January 27, 2023,approximately 20,000 individuals had joined the census registry. What is meant by "high heat and humidity" being one of the causes of this issue? Do affected units exhibit features that customers / users should watch out for? Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. Click "Next". Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX. We thank you for your patience as we work to restore your trust. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. How can I tell if a recent call, letter or email is really from Philips Respironics? How are you removing the old foam safely? The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. 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 (International markets) / voluntary recall notification (U.S. only). For more information on the recall notification (U.S. only) / field safety notice (International Markets), as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update. Philips is notifying customers and users of affected devices that the company will replace the current sound abatement foam with a new material that is not affected by this issue. The criminal and civil investigation is being conducted by the DOJs Consumer Protection Branch and Civil Fraud Section and the US Attorneys Office for the Eastern District of Pennsylvania, Collectiveand individual civil complaints have been filed in various jurisdictionsglobally, including but not limited to the United States, Australia,Canada, Israel and Chile. The potential risks of degraded foam exposure include: Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . 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. Philips believes SoCleans claims have no basisin fact or law and is seeking dismissal of the case in its entirety,including on the basis that the FDA has stated that CPAP ozone cleaners,like SoCleans products, are not legally marketed for this use., In the Eastern District of New York, a securities class action suit was filedagainst the company in August 2021, alleging Philips statements inconnection with the recall triggered a fall in stock price. Not discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps any reports patient... The website also provides Instructions on how to locate an affected device websites often end.gov! We are providing agencies with required information related to the initial launch and ongoing implementation of the of. That our teams are working on a comprehensive correction program to support patients with an affected Serial... 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