FDA Safety Communication:
The U.S. Food and Drug Administration (FDA) is alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines. Philips Respironics has recalled certain devices (see table below) due to potential health risks. The foam used to reduce sound and vibration may break down. This can potentially enter the device’s air pathway. Debris from the foam may be released into the device’s air pathway. These may be inhaled or swallowed by the person using the device.
If you use one of these affected devices (see table below), fill out form below. Also talk to your insurance, device company and health care provider. They will decide on a suitable treatment for your condition. Also follow the recommendations listed below.
Philips Respironics is recalling these devices manufactured between 2009-21. For details, see Philips’ Respironics recall notification.