The FDA and Phillips Respironics provided updates on the mechanical ventilators that were recalled in June 2021 resulting in more than 21,000 medical device reports, 124 of which were tied to deaths.
"We are replacing or repairing the devices related to the Respironics field action as fast as possible and are continuing to update patients and customers about the progress of the program," David Ferguson, business leader of Philips Respironics, said in the May 24 statement. "More than 1,000 of our colleagues are working around the clock on every aspect of the remediation."
The FDA is not changing its initial recommendations from June 2021, according to the May 19 notice.