Enforcement Report - Week of September 19, 2012
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Event Detail
| Event ID | 62989 |
|---|---|
| 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 | US Nationwide Distribution including the states of: GA, IA, KS, NC and TX. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system | Model number 10273100 - serial numbers 1034, 1038, 1041, 1042, 1043, 1050, 1053, and 1054 | Class II | During regular product monitoring, firm became aware of a potential issue with the Mobilett Mira system, (serial numbers 1034, 1038, 1041, 1042, 1043, 1050, 1053, and 1054. During normal clinical operation the center screw on the driving wheel may become loose resulting in system immobilization. There is no risk of the system tipping over or collapsing on the floor, however the system may tilt to the floor on one side. | 9 | Z-2367-2012 |
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