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U.S. Department of Health and Human Services

Class 2 Device Recall Zoll

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  Class 2 Device Recall Zoll see related information
Date Initiated by Firm June 23, 2003
Date Posted July 10, 2003
Recall Status1 Terminated 3 on December 29, 2020
Recall Number Z-1000-03
Recall Event ID 26590
510(K)Number K972241  
Product Classification Automated External Defibrillators (Non-Wearable) - Product Code MKJ
Product Zoll M Series External Defibrillator
Code Information Serial Numbers: T02I37097-T03C45238
Recalling Firm/
Manufacturer		 Zoll Medical Corporation
32 Second Avenue
Burlington MA 01803
For Additional Information Contact Paul Dias
800-348-9011
Manufacturer Reason
for Recall		 Defibrillator may fail to charge or hold its charge above energies of 75 joules
FDA Determined
Cause 2		 Other
Action Zoll Medical issued a letter on 6/25/03 to domestic consignees and 6/26/03 to international consignees on 6/26/03. Letters were issued Certified Mail Return Receipt requested. Instructions are provided for Biomedical to charge device and then dump the charge. A damaged device will fail to charge and issue an error message. Users then are requested to return device. Firm will initiate telephone contact on 6/30/03 to all accounts to verify receipt of notice and confirmation of testing per the instructions.
Quantity in Commerce 8,142 units
Distribution Nationwide Foreign: Emirates, Australia, Brussels, Brazil, Canada, China, Columbia, Chezche, Germany, Spain, Finland, France, Greece, Hong Kong, India, Indonesia, Italy, Japan, Korea, Kuwait, Latvia, Mexico, Netherlands, Poland,Romania, Saudi Arabia, Syrai, Thailand, Turkey,
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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