Siemens Mobilett Mira mobile x-ray system recallZ-2367-2012 · Siemens Medical Solutions USA, Inc · initiated Apr 30, 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, 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
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-2367-2012
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 30, 2012
- Posted by the FDA
- Sep 11, 2012
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 9
- Product code
- IZL
- FDA submissions
- K111912
- Distribution
- US Nationwide Distribution including the states of: GA, IA, KS, NC and TX.
Product description
Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system
Code information (models, lots, serial numbers)
Model number 10273100 - serial numbers 1034, 1038, 1041, 1042, 1043, 1050, 1053, and 1054
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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