- On April 26, 2021, Philips provided an important update regarding proactive efforts to address identified issues with a component in certain products of our Sleep and Respiratory Care portfolio.
- At that time, out of an abundance of caution and based on available information, Philips advised of potential health risks related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. The company also indicated that analysis of potential health risks was ongoing, and that further information would be provided when available.
- As a result of extensive ongoing analysis following this announcement, on June 14, 2021, the company issued a recall notification for specific affected devices.
- The recall notification 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.
To date, Philips has received a limited number of reports of possible patient impact due to foam degradation, and no reports to date regarding patient impact related to chemical emissions. The company continues to monitor reports of potential safety issues as required by medical device regulations and laws in the markets in which we operate.
- The recall notification advises patients and customers to take the following actions:
1. For patients using BiLevel PAP and CPAP devices: Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks.
2. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps.
- 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.
- We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible.
- The company has developed a comprehensive plan to replace the current sound abatement foam with a new material that is not affected by this issue, and has already begun this process.
- 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 philips.com/SRC-update. In the US, affected parties may also call, toll free, 877-907-7508.