Enforcement Report - Week of October 17, 2012
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Event Detail
| Event ID | 63045 |
|---|---|
| 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 | 2012-06-06 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution including the states of MO, FL, MA, NY, WI, GA, CA and WA. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Siemens syngo.plaza radiological image processing system. | Model number 10592457, serial numbers 100263, 100401, 100177, 100138, 100174, 100406, 100249, 100201, 100198, 100181, 100146. | Class II | Siemens became aware of an unintended behavior when using syngo.plaza. In syngo.plaza within the online "Short Time Storage" (STS), some studies are marked with an archived icon, however, the entry in the Archive Database referring to the physical file may be missing. | 11 | Z-0048-2013 |
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