By Stephen Nakrosis

 

Royal Philips said Friday its Philips Respironics subsidiary is notifying customers about a voluntary recall of its V60/V60 Plus and V680 ventilators.

The U.S. Food and Drug Administration classified the recall as a Class I, its most serious type of recall, the company said.

The V60/V60 Plus is an assist ventilator and the V680 ventilator provides invasive and non-invasive respiratory support. The company said there is a potential issue with a circuit controlling the power supply in the units which may cause the device to stop operating, potentially without setting off an alarm.

Royal Philips said customers could implement an oxygen analyzer with appropriate alarm settings for each unit and connect the unit to a nurse call/remote alarm system. It projected an average of less than one silent shutdown among 1 million uses per year.

Royal Philips said the voluntary recall notification is only for the U.S. only and a field safety notice for the rest of the world.

Royal Philips said it booked a provision in its fourth quarter in connection with the recall.

 

Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

 

(END) Dow Jones Newswires

April 22, 2022 11:56 ET (15:56 GMT)

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