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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 Device Recall AutoPulse Resuscitation Systemsee related information
Date Initiated by FirmAugust 08, 2012
Date PostedJanuary 09, 2013
Recall Status1 Terminated 3 on May 12, 2014
Recall NumberZ-0658-2013
Recall Event ID 62950
510(K)NumberK011046 K022345 K032852 K040453 K063602 
Product Classification Compressor, cardiac, external - Product Code DRM
ProductAutoPulse 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 CA 94085-3513
For Additional Information ContactSam Nanavati
408-419-1030
Manufacturer Reason
for Recall		Complaints associated with an unexpected stop in AutoPulse compressions.
FDA Determined
Cause 2		Employee error
ActionZoll 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 Commerce3881 in US, 1846 ROW.
DistributionWorldwide distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DRM
510(K)s with Product Code = DRM
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