On the same day that Philips announced its new president and CEO—Roy Jakobs, who has held responsibility for the voluntary recall notification/field safety notice for specific Respironics devices on behalf of Philips—the FDA updated a safety communication regarding the ongoing recall issues of the company’s respiratory devices.
In only a little over a year, the FDA has racked up more than 69,000 complaints linked to Philips’ recall of millions of its breathing support devices—after receiving only 30 such reports in the entire decade preceding the start of the recall in June 2021.
The bulk of those post-recall complaints flooded in within the last three months, the agency said in an update this week to its safety notice about the recall. According to the FDA, between May 1 and July 31, it received more than 48,000 medical device reports linked to the respiratory device issues, including 44 reports of death.
Read the full story at Fierce Biotech.