Medical Device recall notification (U.S. only) / field safety notice (International Markets)

Phillips Respironics announced a voluntary recall for continuous and non-continuous ventilators  (certain CPAP, BiPAP, and ventilator devices) due to two issues related to the polyester based polyurethane PE-PUR) sound abatement foam used in these devices.   To see if you device is affected and obtain updated information, please visit  https://www.usa.philips.com/healthcare/e/sleep/communications/src-update.

 

Please inspect your machine for the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask).   If seen, please discontinue use of your machine and contact your durable medical equipment company and/or Respironics directly @ (877)907-7508 to inquire about repair or replacement.

If no debris or particles are seen, we recommend that you continue using your BiLevel PAP, CPAP, or mechanical ventilator,  as the benefits of continued therapy outweigh potential risk.

We also advise that you STOP using any automatic cleaners immediately!  Please review and adhere to your device Instructions for Use for approved cleaning methods.