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U.S. Department of Health and Human Services

Class 2 Device Recall Zoll AED Plus Defibrillator

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 Class 2 Recall
Zoll AED Plus Defibrillator
see related information
Date Posted February 06, 2003
Recall Status1 Open
Recall Number Z-0548-03
Recall Event ID 25245
Product Zoll AED Plus Defibrillator (Automatic External Defibrillator)
Code Information Serial Numbers: X02F000812 through X02K007486
Recalling Firm/
Zoll Medical Corporation
32 Second Avenue
Burlington, Massachusetts 01803
For Additional Information Contact Paul Dias
Manufacturer Reason
for Recall
Defibrillator may fail to function due to false detection of safety fault condition
Action Zoll Medical notified Direct accounts by letter issued Overnight Certified Mail on 12/17/02 to Domestic Accounts and 12/18/02 to International accounts. .
Quantity in Commerce 5,597 units
Distribution Nationwide to : Hospitals, EMT, Police and Fire Rescue

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55