FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system
- Recall number
- Z-2367-2012
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system
- Status
- Terminated
- Initiated
- 2012-04-30
- Posted
- 2012-09-11
- Terminated
- 2012-09-25
- 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.
- Lot, serial or model codes
- Model number 10273100 - serial numbers 1034, 1038, 1041, 1042, 1043, 1050, 1053, and 1054
- 510(k) numbers
- ["K111912"]
- PMA numbers
- not on file
- Product code
- IZL
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28