Certain Philips Ventilators, BiPAP, and CPAP Machines Recalled

The PE-PUR foam, used to reduce sound and vibration in the affected devices, may break down and potentially enter the device's air pathway.

If your email program has trouble displaying this email, view as a webpage. Certain Philips Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks - FDA Safety Communication Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to alert people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in the 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, talk to your health care provider to decide on a suitable treatment for your condition and follow the recommendations listed in the safety communication. Read More This safety communication provides: A list of recalled devices Recommendations for people who use these devices, their caregivers, and health care providers and facilities. Background on the issue and the FDA's actions to address the issue. Instructions for reporting problems with these devices to the FDA. Questions? For more information on the recall notification, contact your local Philips representative or visit Philips Respironics' recall notification web page.

Follow us on Twitter at @FDADeviceInfo Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA