FDA Cites AED Battery Life As Cause for Concern in Warning Letter to Zoll

FDA Cites AED Battery Life As Cause for Concern in Warning Letter to ZOLL

AED manufacturer ZOLL received a warning letter from the Food & Drug Administration for failing to validate the battery life of its AEDs. >From September 2009 to January 2011, the FDA alleges ZOLL received 15 complaints of battery failure before expiration dates. The letter also alleges that ZOLL did not implement a life-cycle test plan, though one had been developed. In a posting on its Web site, ZOLL acknowledged receipt of the letter and agreed to provide additional data to the FDA