Dutch medical device maker Philips said on Monday it has expanded an earlier recall of some respiratory machines to a total of 1,700 devices globally due to possible contamination of a plastic component with a non-compatible material.
The company’s subsidiary, Philips Respironics, has not received any reports of patient harm due to the issue but announced the recall to prevent future occurrences, a Philips spokesperson said.
The 1,700 devices also include 386 in the United States, but none in the company’s home country, the Netherlands-based Philips said.
The U.S. Food and Drug Administration first announced the recall on Monday, saying that if the plastic is in the device motor of the bi-level positive airway pressure (BiPAP) machines, it may release certain chemicals of concern called volatile organic compounds.
Philips distributed the 386 affected BiPAP machines in the United States between Aug. 6, 2020 and Sept. 1, 2021 and sent an urgent medical device recall letter to the affected customers on Friday, the agency said.
However, only machines with certain serial numbers identified by the company are affected by this recall, the FDA said.
This recall is not associated with last year’s call back of millions of breathing devices and ventilators due to the potential of a foam part degrading and becoming toxic, possibly causing cancer.
However, some of the devices recalled last year may also have faulty plastic parts that triggered the latest recall, the FDA said.
“All affected devices with the non-conforming plastic will therefore be remediated in the June 2021 field action,” the company said.
Philips’ market value has slumped by over two-thirds since last year’s recall, leading the company to replace Frans van Houten with Roy Jakobs as chief executive officer in mid-October.
By Leroy Leo