Enforcement Report - Week of March 20, 2013
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Product Detail
| Product Description | Siemens Somatom CT's equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system. |
|---|---|
| Recall Number | Z-0948-2013 |
| Classification | Class II |
| Code Info | Model numbers - 7740769, 8098027, 10430603, and 10590000. |
| Product Distributed Qty | 896 |
| Reason For Recall | Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality. |
Event Detail
| Event Id | 64376 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| City | Malvern |
| State | PA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-11-27 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution. |
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