In addition to a U.S. DOJ inquiry, Philips now faces an investigation from French prosecutors over its recall of sleep apnea machines and ventilators.
French prosecutors opened a preliminary investigation into Philips Respironics’ recall of its sleep apnea machines and ventilators, Reuters reported Thursday, citing a text message from the Paris public prosecutor’s office.
The office has taken up complaints filed on the grounds of “aggravated deception, involuntary attacks on physical integrity, endangerment of life of others and administration of harmful substances," according to the text message.
Philips began its recall of more than 5.5 million ventilators and sleep apnea devices in June of last year. It started pulling the devices after reports that the foam used to soundproof the machines was degrading and being inhaled by users, potentially exposing them to toxic chemicals.
In addition to the French investigation, the company has also been facing a probe by the U.S. Department of Justice. Recently, Philips said that it was in consent decree negotiations with the DOJ related to the recall, although it has not yet disclosed the terms.
Philips CEO Frans Van Houten is set to step down next month , with Roy Jakobs, who leads the company’s connected care business and who oversaw the Respironics recall, taking his place.
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Aging medtech and increasingly sophisticated criminals are leaving hospitals highly vulnerable to attacks.
AdvaMed backed the nomination, noting a new Medicare rule that gives developers of FDA-designated breakthrough devices the potential to sell them and be reimbursed on the day of market approval.
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