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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 Initiated by Firm December 17, 2002
Date Posting Updated February 06, 2003
Recall Status1 Terminated 3 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/
Manufacturer
Zoll Medical Corporation
32 Second Avenue
Burlington MA 01803
For Additional Information Contact Paul Dias
781-265-9413
Manufacturer Reason
for Recall
Defibrillator may fail to function due to false detection of safety fault condition
FDA Determined
Cause 2
Other
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = ZOLL MEDICAL CORP.
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