June 8, 2022
FDA: Class I recall of Philips Respironics V60, V60 Plus Ventilators
Editor's Note
The Food and Drug Administration on June 3 identified the recall by Philips Respironics of all V60 and V60 Plus Ventilators as Class I, the most serious.
The recall was initiated because an internal power fluctuation may cause the ventilator to shut down unintentionally with or without any visible or audible alarms. Such failures may lead to patients being deprived of oxygen for an extended time.
As of April 14, there have been 4 injuries and 1 death reported. Distribution dates were May 1, 2009, to December 22, 2021.
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