- If you have not done so already, please click here to begin the device registration process.
- Our update in November 2021 provides broadened guidance regarding affected CPAP, BiLevel PAP and Mechanical Ventilator devices, and mechanical ventilators, as follows:
For patients using BiLevel PAP and CPAP devices, talk to a health care provider to decide on a suitable treatment for medical conditions, which may include:
- Stopping use of an affected device
- Using another similar device that is not part of the recall
- Continuing to use an affected device, if a patient’s health care provider determines that the benefits outweigh the risks identified in the recall notification.
- Using alternative treatments for sleep apnea.
For patients using life-sustaining mechanical ventilator devices, they should not stop or change ventilator use until they have talked to their health care providers regarding factors including:
- Whether in the judgement of the treating clinical team the benefit of continued usage of these ventilator devices may outweigh the potential risks identified in the recall notification.
- Consultation with health care providers about using an inline bacterial filter with ventilators, which may help to filter out particles of foam, as indicated in the Philips recall notification, which also notes limitations of this option and areas of caution.
- We strongly recommend that customers and patients do not use ozone-related cleaning products. Additionally, we remind both 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.
- Please be assured that we are treating this matter extremely seriously, and are working to address this issue as efficiently and thoroughly as possible.
- We have developed a comprehensive plan to replace the current sound abatement foam with a new material that is not affected by this issue and have already begun this process.
- For more information on the recall notification (U.S. only) / field safety notice (Outside of U.S.), as well as instructions for customers, users and clinicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update
- If you are a patient who has been affected by this recall, do not try to remove the foam from your device. Doing this could affect the prescribed therapy and may void the warranty. We have trained service professionals on hand who can make sure that the affected foam is completely removed, safely, and that the new silicone foam is inserted correctly.