FDA releases alert on Philips BiPAP machines

WASHINGTON – The U.S. Food and Drug Administration is alerting patients, caregivers and health care providers that Philips Respironics has recalled 386 affected bi-level positive airway pressure (BiPAP) machines that may contain a plastic contaminated with a non-compatible material. 

“If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs),” the FDA stated. “The plastic may also cause the machine to fail and stop working suddenly during use.” 

This new recall is not associated with the sound abatement foam impacting certain BiPAP machines recalled in June 2021. This new recall, however, does apply to some of the devices recalled in June 2021. 

Philips distributed the affected BiPAP machines in the U.S. between August 6, 2020, and September 1, 2021. Philips sent affected customers, including DME providers, an Urgent Medical Device Recall letter on Aug. 26. 

The models, some of which are intended for use only in clinical environments, are A-Series BiPAP A30 (ventilator), A-Series BiPAP A40 (ventilator), A-Series BiPAP V30 (auto ventilator) and OmniLab Advanced+, but only machines with the serial numbers identified in the company’s Urgent Medical Device Recall letter are affected by this recall. 

Philips recommends that health care providers locate all recalled devices in their facilities. It also recommends: 

For the A-Series BiPAP V30 (auto ventilator) and OmniLab Advanced+ machines, which are intended for use only in clinical environments and which are not a part of the June 2021 recall, replace with an unaffected device or discuss with your patient (or their caregiver, as appropriate) whether their plan for care and treatment should change as a result of this recall. 

For the A-Series BiPAP A30 (ventilator) and A-Series BiPAP A40 (ventilator) machines, which are intended for use in either clinical environments or by patients at home and which were also included in the June 2021 recall, no action is needed if the device was already corrected or replaced through the June 2021 recall, as the affected plastic components were also replaced. If the device was not already corrected or replaced, register the device, if not done already, on the Philips website and discuss the best treatment course.