Enforcement Report - Week of December 12, 2012
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Event Detail
| Event ID | 63521 |
|---|---|
| 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 | 2012-06-20 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide distribution: USA including states of: CA, FL, GA, MA, MN, MO, NJ, NY, OH, and WI. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System | Model number 10 592 457 | Class II | Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instruction. The Update Instruction SY050/12/S provides a software update and addresses the following issues: - Patient Rename messages for the same patient are being continually processed for several days. This fills up the 'pcvdbsrv' log and potentially affects performance of the system. - Data could remain unprotected and not archived leading to a potential data loss. - System crashes when user tries to delete a self created spine labeling step. - For datasets with corrupt PR objects, not all images are loaded to Viewer and no Ferro message is displayed for the user. - 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. - Viewer crashes during load of next patient. Error is related to 'Next Patient' from RIS. | 15 | Z-0465-2013 |
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