 FDA
classifies Philips ventilator recall due to low oxygen
risk as most serious
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[August 04, 2021]
(Reuters) - The U.S. Food and Drug
Administration on Tuesday classified the recent recall of some of
Philips' ventilators as Class 1, or the most serious type of recall,
saying the use of these devices may cause serious injuries or death.
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 This is the second Class 1 recall initiated by the company this
year.
In June, the Dutch medical equipment company also recalled some of
its breathing devices and ventilators, as the foam used to dampen
the machines' sound could degrade and emit small particles that
irritate airways.
The FDA said on Tuesday there have been 61 incidents and 25 injuries
through the products recalled recently, but no deaths were reported
for these issues.
The company initiated the second recall also in June and has so far
recalled 16,535 devices in the United States.
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 Philips has recalled the V60
and V60 Plus ventilators, as there is a risk of
patients receiving reduced oxygen in certain
situations which could lead to adverse events.
The devices have a design safety mechanism that
limits the amount of oxygen flow in situations
where the system pressure reaches a default
maximum pressure limit, due to a partial
obstruction in the breathing circuit, according
to the FDA.
(Reporting by Mrinalika Roy in Bengaluru;
Editing by Maju Samuel)
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