FDA: Class I recall of Philips Respironics V60, V60 Plus Ventilators

Editor's Note

The Food and Drug Administration (FDA) on March 21 identified the recall by Philips Respironics of certain V60 and V60 Plus Ventilators as Class I, the most serious.

The recall was initiated because a subset of these devices had parts that were put together using an expired adhesive. If the adhesive fails, it could cause a capacitor support bracket to loosen and damage the capacitors, which could cause the ventilator to stop providing ventilation. The failure may or may not sound an alarm, and the patient may be deprived of oxygen for an extended time.

To date, there have been no reports of injuries, adverse health consequences, or deaths associated with the use of these ventilators.

Distribution dates were July 29, 2021, to August 11, 2021.