The FDA has designated a Philips Healthcare ventilator recall as Class I. U.S. regulators said Friday that they think the roughly 600 Philips Respironics Trilogy Ventilators in question could cause serious injury or death because of a power management board issue that could cause the ventilators to not actually deliver mechanical breaths. In announcing a voluntary recall on February 11, Philips’ Respironics Inc. business said there had been no reports of death or serious injury related to the problem.
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