On August 29, 2022, Yahoo News reported that Philips, the Dutch medical device maker, announced that the company was expanding its previous breathing machine device recall. This expansion was initiated after the company discovered that some of its respiratory machines might be contaminated with a non-compatible material. The recall will increase the number of breathing machines recalled by Philips to more than 1,700 additional devices. Philips Respironics, the company’s subsidiary, stated that they had not yet received any adverse incident reports of harm to users. However, the recall was initiated to prevent future happenings, a spokesperson for Philips stated.
This recall includes 386 units sold in the United States. None of the recalled breathing machines were sold in Philip’s home country of the Netherlands.
According to the U.S. Food and Drug Administration, this is the first breathing machine recall concerning plastic parts inside the device’s motor and only affects certain bi-level positive airway pressure (BiPAP) machines. The chemicals of concern are known as “volatile organic compounds.” These plastics release these volatile organic compounds, and the toxic chemical fumes can harm patients.
Philips circulated the 386 defective BiPAP machines throughout the United States between August 6, 2020, and September 1, 2021. Philips issued an urgent medical device recall letter to customers who purchased the affected breathing machines. The FDA states that the recall impacts breathing machines that have certain serial numbers identified by the company. This recall is not connected to last year’s recall involving foam parts degrading and dispensing toxic, possibly causing cancer chemicals and fumes.
The affected BiPAP machines include:
- A-Series BiPAP A30 (Ventilator)
- A-Series BiPAP A40 (Ventilator)
- A-Series BiPAP V30 (Auto Ventilator)
- OmniLab Advanced+
The FDA stated that some devices recalled last year might have faulty plastic parts triggering this recall. Philips added that all affected breathing machines that have non-conforming plastic would be fixed in the June 2021 field action.
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