Recall Z-2367-2012 ยท IZL System, X-Ray, Mobile
Siemens Medical Solutions USA, Inc
Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system
| Date | Sep 11, 2012 (initiated Apr 30, 2012) |
| Status | Terminated |
| Reason | 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 t |
| Root cause | Device Design |
| Action | Siemens has issued an Update Instruction XP018/12S in April 2012 to all affected consignees notifying them of the problem. The update instruction provides a correction of the wheel fixation. For questions call Siemens at 610-219-4834 or 610-448-4634. |
| Quantity | 9 |
| Distribution | US Nationwide Distribution including the states of: GA, IA, KS, NC and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111912 | MOBILETT MIRA Siemens Medical Solutions USA, Inc., Sep 19, 2011 |