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The FDA announced today that it is labeling another Philips Respironics recall as Class I, its most serious classification.

The new recall involves 386 ventilators distributed from Aug. 6, 2020, to Sept. 1, 2021. The BiPAP machines may contain plastic in their motors that could release volatile organic compounds (VOCs). On top of the risk of users inhaling dangerous VOCs, the plastic could also cause device failure.

At this time, the FDA is not aware of any reports of serious injury or death. The BiPAP machines can treat both adults and children at home and in clinical environments, including hospitals and sleep laboratories.

The latest serious recall comes as Philips continues to grapple with a deadly recall that involves more than a million CPAPs, ventilators and other respiratory devices. Problems stem from polyester-based polyurethane sound abatement foam that could break down. Foam particles could enter a device’s air pathway. The particles could cause a range of potential health problems and toxic, carcinogenic effects for the user.

The sound abatement foam recall has effectively removed Philips from the respiratory devices market for now. Roy Jakobs, the company’s Connected Care chief businesses leader who has been in charge of the recall, is slated to become CEO next month.

The FDA and federal prosecutors are increasingly scrutinizing how Philips has handled the recall. In addition, French prosecutors have opened a preliminary investigation. The FDA wants Philips to submit a plan for device repair, replacement or refund.

In addition to the sound abatement foam and motor plastic recalls, Philips and the FDA have warned that about 17 million CPAP and BiPAP masks with magnetic headgear clips or straps could negatively interact with implanted metallic medical devices. Philips has reported 14 serious injuries, including pacemaker failure, arrhythmia, seizures and irregular blood pressure related to the recalled masks, according to the FDA.

Product models involved in the latest recall include the A-Series BiPAP A30 (ventilator), A-Series BiPAP A40 (ventilator), A-Series BiPAP V30 (auto ventilator), and the OmniLab Advanced+. The FDA’s website includes detailed product descriptions.

Phillips sent affected customers an Urgent Medical Device Recall letter on August 26, 2022. It noted that it’s already swapped out the affected plastic components in devices corrected or replaced in the sound abatement foam recall.

Filed Under: Featured, Food & Drug Administration (FDA), News Well, Recalls, Regulatory/Compliance, Respiratory Tagged With: Philips, Philips Respironics

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