Philips Respironics announced a voluntary recall notification (U.S. only) / field safety notice (International Markets) for Continuous and Non-Continuous Ventilators (certain CPAP, BiLevel PAP and Ventilator Devices) due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices: 1) PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and 2) the PE-PUR foam may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone (see FDA safety communication on use of ozone cleaners), and off-gassing may occur during initial operation and may possibly continue throughout the device’s useful life. For a list of all affected products, please visit our main recall notification (U.S. only) / field safety notice (International Markets) page. Philips is working tirelessly to remedy this issue by replacing the affected devices. A recall notification (U.S. only) / field safety notice (International Markets) with immediate actions to be taken has been sent to distributors and institutions that are a direct customer of Philips for their own use as well as for engagement with patients. With this, your patients are likely to contact you for guidance and we are committed to providing you with information and tools to have an informed discussion with them and make your clinical recommendation. Please see the FAQs below and Clinical Information PDF here. For the past 40 years we have centered our business around our commitment to patient care, with solutions that are aimed at improving the lives of people with respiratory and sleep challenges. We recognize the importance of providing safe and effective therapy. We are committed to holding ourselves to the highest standards of product quality and safety in an effort to do what is right for you, and the patients who trust you with their care. We are committed to resolving this issue and providing transparent, ongoing communication as we navigate the next steps. We are committed to providing you information and resources for your own understanding, but also to help you communicate with your patients effectively and efficiently. We sincerely apologize for this disruption. We are fully committed to supporting you and your patients throughout this process.
For other inquiries or to speak with a support specialist, you can also call 1800-999-119.
FOR BILEVEL PAP AND CPAP DEVICES Discontinue use of affected BiLevel PAP and CPAP devices, and consult with physicians to determine the most appropriate options for continued treatment, based on the benefits of continuing therapy and potential identified risks. FOR LIFE-SUSTAINING VENTILATOR DEVICES FOR ALL DEVICES The website provides current information on the status of the recall notification (U.S. only) / field safety notice (International Markets) and how to receive permanent corrective action to address the two issues. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. Call 1800-999-119 if you cannot visit the website or do not have internet access. Philips is recommending that customers and patients do not use ozone-related cleaning products, and adhere to their device Instructions for Use for approved cleaning methods. Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are recommended to be replaced after five years of use.
Do not stop or alter prescribed therapy on affected life-sustaining mechanical ventilator devices, without consulting with physicians.
The recall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions: Philips is recommending that customers and patients halt use of ozone-related cleaning products, and adhere to their device Instructions for Use for approved cleaning methods. 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 recall notification (U.S. only) / field safety notice (International Markets) 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 emissions from the foam material. High heat and high humidity environments may also contribute to foam degradation in certain regions. Philips continues to monitor reports of potential safety issues through our post-market surveillance activities as required by medical device regulations and laws in the markets in which we operate. In the event of exposure to degraded foam: In the event of exposure to chemical emissions:
Philips is notifying regulatory agencies in the regions and countries where affected products are available. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. The company will replace the current sound abatement foam with a new material that is not affected by this issue, and has already begun this process. At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible.
At this time, affected devices are on manufacturing and ship hold as the company prepares to implement the repair / replacement program for affected devices, to install new sound abatement foam material not affected by the reported issues.
The issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. This recall notification / field safety notice has not yet been classified by regulatory agencies.
We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. As a result of extensive ongoing analysis, on June 14, 2021, the company issued a recall notification for specific affected Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. The recall notification (U.S. only) / field safety notice (International Markets) 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 emissions from the foam material. 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. 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. The new material will also replace the current sound abatement foam in future products. Philips is recommending that customers and patients halt use of ozone-related cleaning products, and adhere to their device Instructions for Use for approved cleaning methods. 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 company has dedicated significant resources to address this issue, and has developed a comprehensive plan for this correction, and has already begun this process. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. Philips deeply regrets the inconveniences caused by this issue, and we are dedicating significant time and resources to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority. For more information on the recall notification, as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update. Call 1800-999-119 if you cannot visit the website or do not have internet access.
Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). The recall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions: The company has developed a comprehensive plan for this correction, and has already begun this process. Philips is recommending that customers and patients halt use of ozone-related cleaning products, and adhere to their device Instructions for Use for approved cleaning methods. 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. Philips deeply regrets the inconveniences caused by this issue, and we are dedicating significant time and resources to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority. 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. Call 1800-999-119 if you cannot visit the website or do not have internet access.
Based on Philips analysis, the root cause of this issue is related to the sound abatement foam currently used in specific identified products of the Sleep & Respiratory Care portfolio.
Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. The products were designed according to, and in compliance with, appropriate standards upon release. As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. Philips Quality Management System has been updated to reflect these new requirements. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. The foam degradation and chemical emission issues were discovered as part of our Quality Management System processes, and are being corrected in accordance with appropriate regulatory requirements. Philips has been in full compliance with relevant standards upon product commercialization.
Philips has determined that the foam may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods, such as ozone), and certain environmental conditions involving high humidity and temperature. 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. This factor does not refer to heat and humidity generated by the device for patient use.
Users should consult with their physicians as directed in the recall notification (U.S. only) / field safety notice (International Markets).
Affected devices may be repaired under warranty. Philips will provide further information regarding warranty replacement procedures during this issue when it is available.
At this time, Philips is unable to set up new patients on affected devices. Philips may work with new patients to provide potential alternate devices. Philips may repair / replace ventilator units that patients are reliant on in emergency situations such as device failure during required treatment, to ensure continuity of care. Philips CPAPs cannot be replaced during ship hold.
Philips has completed our analysis in accordance with our Quality Management System and identified all affected products, which are included in our notifications to regulatory agencies and customers. No further products are affected by this issue.
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