Philips RespironicsThe 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.
