by
John R. Fischer, Senior Reporter | April 20, 2022
Philips’ V60 and V60 Plus ventilators were previously
recalled last June and deemed as Class I then as well after a software issue created the risk of reducing oxygen flow to patients in certain situations.
The FDA said the devices could result in serious injury or death and traced 61 incidents and 25 injuries back to them at the time. It said patients affected by these adverse events could require advanced medical treatment, with some cases involving a degree of hypoxemia.
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In the same month, Philips also recalled millions of its continuous positive airway pressure and bilevel positive airway pressure (BiPAP) machines, which are designed for sleep apnea, when it was found that the polyester-based polyurethane (PE-PUR) sound abatement foam on them was breaking down. This allowed the foam particles to enter the device’s air pathway, which put patients in danger of potential health problems and toxic, carcinogenic effects.
As a result, the company announced that it would no longer take orders for sleep therapy systems and leave the sleep therapy market for at least a year to address the recall, according to Mass Device.
And last month, certain V60 and V60 Plus ventilators were flagged due to having parts
held together by an expired adhesive. Were the adhesive to fail, parts could become loose and the ventilator could shut down. The alert pertained to 1,511 devices distributed in the U.S. from July 29, 2021 to August 11, 2021, according to the FDA.
Additionally, the agency told Philips in March that its notification efforts on the recall of its ventilators have been inadequate to date, and that it will require the company to do a better job of notifying all device users, durable medical equipment suppliers, distributors, retailers and healthcare providers who inquire about the recalls and risks associated with them.
Philips Respironics will provide regular updates to customers on the development of its plan to address the issue with the three ventilators, with the first update to be provided before June 30, 2022.
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