FDA Slaps Class I Recall Tag on Royal Philips Electronics N.V. Respironics V60 Ventilator

Philips Respironics The FDA today labeled a recall of Royal Philips Respironics‘ V60 ventilators as Class I.

Class I recall designations, the agency’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.

The Respironics V60 non-invasive ventilator is designed to provide continuous or intermittent breathing support to pediatric patients weighing at least 44 lbs or adult patients, according to the recall notice.

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