FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens Mobilett Mira. Mobile X-Ray System.
- Recall number
- Z-2322-2012
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens Mobilett Mira. Mobile X-Ray System.
- Status
- Terminated
- Initiated
- 2012-08-21
- Posted
- 2012-09-06
- Terminated
- 2014-04-03
- Reason
- During regular product monitoring, Siemens has become aware of a potential issue with the Mobilett Mira system. During normal clinical operation the switch on the motor drive handle of the unit may become loose and slide horizontally to the right and become trapped under the cover. This may cause the system to continuously move. In response, Siemens has issued Update Instruction XP038/12/S to r
- Root cause
- Device Design
- Action
- Siemens initiated their correction of the MOBILETT Mira on August 21, 2012 by sending an "UPDATE INSTRUCTIONS XP038/12/S to all affected customers. The Instruction identifies the product, problem, and work steps for customers to follow. A XP038/12/S Completion Protocol letter was included for customers to complete and file with the instruction once the update is completed.
- Quantity
- 20
- Distribution
- Nationwide Distribution- including the states of GA, ID, IL, IA, KS, NC, OH, SD, TX, and WI.
- Lot, serial or model codes
- Model number 10273100 -- serial numbers 1034, 1038, 1041, 1042, 1043, 1053, 1057, 1070, 1079, 1081, 1088, 1098, 1099, 1102, 1103, 1105, 1106, 1107, 1108, and 1112.
- 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