Enforcement Report - Week of August 29, 2012
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Product Detail
| Product Description | syngo Dynamics Version 9.5 |
|---|---|
| Recall Number | Z-2219-2012 |
| Classification | Class II |
| Code Info | 10091862 and 10091863 |
| Product Distributed Qty | 30 |
| Reason For Recall | If multiple uncompressed images/clips are sent to the syngo Dynamics server, around the same time, it is possible for an image from a patient to be placed in another patient's study. |
Event Detail
| Event Id | 62581 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Siemens Medical Solutions, USA, Inc |
| City | Ann Arbor |
| State | MI | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-07-13 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution -- MA, GA, MO, IA, CA, PA, OR, CO, NY, NJ, WA, UT, OH, WI, MI, KY, and NC. |
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