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U.S. Department of Health and Human Services

Enforcement Report - Week of January 16, 2013

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Event Detail

Event ID 62950
Product Type Devices
Status Ongoing
Recalling Firm Zoll Circulation, Inc.
City Sunnyvale
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-08
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide distribution.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. all Class II Complaints associated with an unexpected stop in AutoPulse compressions. 3881 in US, 1846 ROW. Z-0658-2013