Philips, a Dutch medical device company, said it has grown a previous recall of some respiratory machines to a total of 1,700 devices worldwide because of the possibility of a plastic element being contaminated with a non-compatible material.
According to a Philips spokesperson, the firm's subsidiary, Philips Respironics has not got any findings of patient harm as a result of the problem, but has issued the recall to avoid future incidences.
According to Philips, the 1,700 devices involve 386 in the United States but none in the homeland of the company.
The recall was first declared by the US Food and Drug Administration on Monday, stating that if the plastic is in the device motor of the bi-level positive airway pressure (BiPAP) machines, it may discharge specific chemicals of concern known as volatile organic compounds.
Philips distributed the 386 impacted BiPAP machines in the United States between August 6, 2020 and September 1, 2021, according to the agency, and issued an urgent medical device recall letter to the affected parties on Friday.
However, the FDA stated that only machines with specific serial numbers recognized by the firm are impacted by this recall.
This recall is unrelated to last year's recall of millions of breathing devices and ventilators due to the possibility of a foam component degrading and becoming toxic, potentially causing cancer.
However, the FDA stated that some of the devices recalled last year may have had faulty plastic parts that triggered the latest recall.
"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 dropped by more than two-thirds since last year's recall, prompting the company to replace Frans van Houten as CEO with Roy Jakobs in mid-October.
(Source:www.usnews.com)
According to a Philips spokesperson, the firm's subsidiary, Philips Respironics has not got any findings of patient harm as a result of the problem, but has issued the recall to avoid future incidences.
According to Philips, the 1,700 devices involve 386 in the United States but none in the homeland of the company.
The recall was first declared by the US Food and Drug Administration on Monday, stating that if the plastic is in the device motor of the bi-level positive airway pressure (BiPAP) machines, it may discharge specific chemicals of concern known as volatile organic compounds.
Philips distributed the 386 impacted BiPAP machines in the United States between August 6, 2020 and September 1, 2021, according to the agency, and issued an urgent medical device recall letter to the affected parties on Friday.
However, the FDA stated that only machines with specific serial numbers recognized by the firm are impacted by this recall.
This recall is unrelated to last year's recall of millions of breathing devices and ventilators due to the possibility of a foam component degrading and becoming toxic, potentially causing cancer.
However, the FDA stated that some of the devices recalled last year may have had faulty plastic parts that triggered the latest recall.
"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 dropped by more than two-thirds since last year's recall, prompting the company to replace Frans van Houten as CEO with Roy Jakobs in mid-October.
(Source:www.usnews.com)
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