Enforcement Report - Week of January 16, 2013
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Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | Z-0658-2013 |
| Classification | Class II |
| Code Info | all |
| Product Distributed Qty | 3881 in US, 1846 ROW. |
| Reason For Recall | Complaints associated with an unexpected stop in AutoPulse compressions. |
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 | Letter |
| Distribution Pattern | Worldwide distribution. |
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