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Class I Recall Ordered for Respironics V60 Ventilator

Filed June 21st, 2013 Joshua Sophy

The U.S. Food and Drug Administration (FDA) has deemed a recall on Respironics V60 Ventilators to be a Class I action.

A Class I recall deemed by the FDA indicates the agency believes use of a drug or medical device could result in serious injuries or death to patients who rely on them.

In a notice from the FDA, the recall on the Respironics V60 ventilator is necessary because of software problems. The software problem is with the V60’s Power Management Board Assembly. Should one of its components fail, the ventilator support could be lost and no audible warning will sound. If a healthcare professional is not aware of the defect and does not hear the warning that the ventilator is not working, the patient who relies on the V60 Ventilator could suffer serious injuries or death, according to a recall notice from the FDA.

The recall on these devices is specific to V60 Ventilators that were distributed between Nov. 16, 2009, and March 28 of this year. In recall notices posted by the FDA to the agency website, there are no indications of injuries or deaths that have resulted from this defect.

These ventilators can still be used if they receive the proper software update. Until then, “customers were instructed to refer to their manual for additional information on warnings” until the software updates can be made, according to the recall notice.

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