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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 Device Recall Zoll Auto Pulse Resuscitation System see related information
Date Initiated by Firm January 28, 2008
Date Posted April 07, 2011
Recall Status1 Terminated 3 on April 28, 2011
Recall Number Z-1904-2011
Recall Event ID 58099
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/
Zoll Circulation, Inc.
650 Almanor Ave
Sunnyvale CA 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
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 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 = DRM and Original Applicant = ZOLL CIRCULATION