Siemens Mobilett Mira recallZ-2322-2012 · Siemens Medical Solutions USA, Inc · initiated Aug 21, 2012
Class II Terminated All recalls posted in September 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-2322-2012
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 21, 2012
- Posted by the FDA
- Sep 6, 2012
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 20
- Product code
- IZL
- FDA submissions
- K111912
- Distribution
- Nationwide Distribution- including the states of GA, ID, IL, IA, KS, NC, OH, SD, TX, and WI.
Product description
Siemens Mobilett Mira. Mobile X-Ray System.
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
1 device cleared under K111912 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Mobilett Mira Max 10594738Siemens Healthcare GmbH · System, x-ray, mobile17 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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