Respironics recalls V60 vents

Tuesday, June 25, 2013

CARLSBAD, Calif. – Respironics California, a Philips Healthcare business, has announced that its worldwide recall of about 19,200 V60 ventilators has been designated a Class I recall by the U.S. Food and Drug Administration (FDA). On June 4, Respironics initiated a voluntary recall to correct a software issue that may cause the vents to shut down. On June 17, following a review, the FDA notified Respironics of the Class I designation, meaning “there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” Respironics discovered the issue through routine product monitoring. Respironics has corrected the software and will make updates on all V60 vents shipped prior to April 1, 2013. FMI: 800-722-9377.