• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Zoll AED Plus Defibrillator

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  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/
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 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.