ZOLL issues corrective action for automated external defibrillators
Device Regulation Alert: Safety, Compliance and Reimbursement News, April 13, 2009
ZOLL Medical Corporation initiated a voluntary field corrective action for 180,000 ZOLL AED Plus automated external defibrillators because some batteries do not work properly and self-test software may not detect the problem, according to a company release.
As a result, the AED Plus defibrillator may not deliver shocks during a sudden cardiac arrest. Devices installed for at least three years have the highest risk, according to ZOLL.
The field corrective action requires users to download and install updated software from the company’s Web site.
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