The U.S. Food and Drug Administration (FDA) is alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices (see table below) due to potential health risks.
The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.
If you use one of these affected devices (see table below), talk to your health care provider to decide on a suitable treatment for your condition and follow the recommendations listed below.
BiPap or CPAP: Recommendations for People Who Use Affected BiPAP or CPAP Machines and Caregivers
- Talk to your health care provider to decide on a suitable treatment for your condition, which may include:
- Stopping use of your device
- Using another similar device that is not part of the recall
- Continuing to use your affected device, if your health care provider determines that the benefits outweigh the risks identified in the recall notification.
- Using alternative treatments for sleep apnea, such as positional therapy or oral appliances, which fit like a sports mouth guard or an orthodontic retainer.
- Initiating long term therapies for sleep apnea, such as losing weight, avoiding alcohol, stopping smoking, or, for moderate to severe sleep apnea, considering surgical options.
- Follow the manufacturer’s instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. Ozone cleaners may worsen the breakdown of the foam, and there are other potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories.
- Register your device(s) on Philips Respironics’ recall websiteExternal Link Disclaimer to stay informed of updates from Philips Respironics regarding any new instructions or other corrective fixes, which the FDA is requiring.
- Report any problems with a device through the FDA’s MedWatch Voluntary Reporting Form.