Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system
FDA device recall Z-2367-2012 · posted 2012-09-11 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 9
- Distribution
- US Nationwide Distribution including the states of: GA, IA, KS, NC and TX.
- Date initiated
- 2012-04-30
- Date posted
- 2012-09-11
- Date terminated
- 2012-09-25
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MOBILETT MIRA (K111912) | Siemens Medical Solutions USA, Inc. | 2011-09-19 |