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RESPIRONICS, INC. ISSUES A GLOBAL RECALL OF DEFECTIVE BREATHING SUPPORT DEVICES

RESPIRONICS, INC. ISSUES A GLOBAL RECALL OF DEFECTIVE BREATHING SUPPORT DEVICES

The FDA recently posted a press release by Respironics, Inc., a Philips Healthcare business, about the worldwide recall of Trilogy Ventilator Models 100, 200 and 202. The Trilogy Ventilator device is used to provide "ventilatory support for the care of individuals who require" artificial respiration.

During production testing, Respironics found that the Trilogy Ventilators contain a "potentially defective" power management component. The component could cause the ventilator to fail delivering mechanical breaths, which might result in "serious adverse health consequences or death." So far, there have been no known serious injuries or deaths related to the discovered issue.

The recall encompasses 600 devices shipped between December 31, 2013, and January 30, 2014. Respironics has "instruct[ed] customers to remove affected devices from service and to return them to Philips for replacement."

Sources:

FDA,

http://www.fda.gov/Safety/Recalls/ucm386490.htm

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm386561.htm

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