The warning letter said Zoll received 15 complaints from Sept. 2009-Jan. 2011 on battery depletion before the calculated five-year battery life cycle was completed. It added that the company developed a life-cycle test plan but failed to implement it.
Following inspections of a company site in Massachusetts, the agency determined that Zoll’s initial battery life cycle validation didn’t account for build-up of a high resistive layer, known as passivation.
Read the FDA warning letter on defibrillators.
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