On Friday, the Food and Drug Administration issued a Class I recall for certain Philips CPAP and BiPAP respirators that were refurbished in an earlier recall, the latest in a string of troubles for the medical device giant. The machines were incorrectly programmed with the wrong serial numbers, leaving some users without the right prescription settings and running the risk that the machines “fail to deliver any therapy at all.”
Because consumers may not be aware the devices are not working correctly, the malfunctioning respirators could result in “respiratory failure, heart failure, serious injury, and death,” regulators warned. The FDA said Philips had received 43 complaints about the issue, but had not received reports of injuries or deaths. The DreamStation respirators are used by patients at home and in health care settings.
The company sent a notice to affected customers in the U.S. and France on February 10 that included the list of serial numbers for the 1,200 affected devices. In an emailed statement, Philips said the company had shipped replacement devices to more than half of the users affected by the serial number error as of April 7.
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