Enforcement Report - Week of September 19, 2012
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Event Detail
| Event ID | 62988 |
|---|---|
| Product Type | Devices |
| Status | Completed |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| City | Malvern |
| State | PA |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-04-30 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide distribution: USA including states of: IN, MI, MS, TN and TX. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Siemens Uroskop Access. Fluoroscopic, image intensified x-ray system | Model number 5756130 -- serial numbers 6076, 6078, 6080, 6081, and 6082. | Class II | Siemens has discovered a possible hazard to patients or hospital personnel when tilting the Uroskop Access system starting with serial number 6076. When tilting the table on the Uroskop Access table, the motor may become disconnected and the entire table assembly may fall on the floor. | 5 | Z-2341-2012 |
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