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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 Device Recall Zoll AED Plus Defibrillator see related information
Date Posted February 06, 2003
Recall Status1 Terminated on April 21, 2004
Recall Number Z-0548-03
Recall Event ID 25245
510(K)Number K011388 
Product Classification Automated External Defibrillators (Non-Wearable) - Product Code MKJ
Product Zoll AED Plus Defibrillator (Automatic External Defibrillator)
Code Information Serial Numbers: X02F000812 through X02K007486
Recalling Firm/
Zoll Medical Corporation
32 Second Avenue
Burlington MA 01803
For Additional Information Contact Paul Dias
Manufacturer Reason
for Recall
Defibrillator may fail to function due to false detection of safety fault condition
FDA Determined
Cause 2
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
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = ZOLL MEDICAL CORP.