Philips Respironics Issues Voluntary Recall of Ventilators
23 April 2022 - 2:11AM
Dow Jones News
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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