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U.S. Department of Health and Human Services

Class 3 Device Recall Zoll Auto Pulse Resuscitation System

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 Class 3 Recall
Zoll Auto Pulse Resuscitation System
see related information
Date Posted April 07, 2011
Recall Status1 Terminated on April 28, 2011
Recall Number Z-1904-2011
Recall Event ID 58099
Premarket Notification
510(K) Number
K072527 
Product Classification Compressor, Cardiac, External - Product Code DRM
Product Zoll Auto Pulse Resuscitation System; Zoll Circulation Inc., Sunnyvale, CA 94085 Cardiac Compressor used as an adjunct to manual CPR. Use of AutoPulse is intended to reduce the impact of rescuer fatigue and enable rescuer to address other patient needs.
Code Information Model 100; AutoPulse product number 8700-0700-xx AutoPulse 1.5G; AutoPulse Battery Part Number 8799-0702-xx
Recalling Firm/
Manufacturer
Zoll Circulation, Inc.
650 Almanor Ave
Sunnyvale, California 94085-3513
For Additional Information Contact James A. Palazzolo
408-541-2140 Ext. 341
Manufacturer Reason
for Recall
Complaints of batteries discharging prematurely and that during use the Auto Pulse Units would cease operating (providing compressions).
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action The firm, Zoll Circulation Inc., initiated a Corrective and Preventive Action Report on January 28, 2009. According to the firm, the customers were contacted by telephone calls and were provided with a Battery Maintenance program. For further questions you may call (408) 541-2140 ext.341.
Quantity in Commerce not provided
Distribution Nationwide Distribution -- including, VA, NY, OH, IN, MO, UT, FL, NC, ME, WA, SD, NM, PA, MS, ID, TX, GA, CA, CO, IL, AR, WV, TN, OR, and KS.
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 = ZOLL CIRCULATION
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