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U.S. Department of Health and Human Services

Class 2 Device Recall AutoPulse Resuscitation System

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 Class 2 Recall
AutoPulse Resuscitation System
see related information
Date Posted January 09, 2013
Recall Status1 Terminated on May 12, 2014
Recall Number Z-0658-2013
Recall Event ID 62950
Premarket Notification
510(K) Numbers
K011046  K022345  K032852  K040453  K063602 
Product Classification Compressor, Cardiac, External - Product Code DRM
Product AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.
Code Information all
Recalling Firm/
Manufacturer
Zoll Circulation, Inc.
650 Almanor Ave
Sunnyvale, California 94085-3513
For Additional Information Contact Sam Nanavati
408-419-1030
Manufacturer Reason
for Recall
Complaints associated with an unexpected stop in AutoPulse compressions.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action Zoll sent Customer Notification letters dated August 8, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Zoll Technical Support Line at 1 (800) 348-9011 for further assistance.
Quantity in Commerce 3881 in US, 1846 ROW.
Distribution Worldwide distribution.
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 = DRM and Original Applicant = REVIVANT CORP.
510(K)s with Product Code = DRM and Original Applicant = ZOLL CIRCULATION
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