Mobiletta Mira recallZ-1875-2013 · Siemens Medical Solutions USA, Inc · initiated May 2, 2013
Class II Terminated All recalls posted in August 2013
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
Siemens issued a Field Safety Alert about the potential risk to users when operating the Mobilett Mira. When a Mobilett Mira is regularly exposed to extensive mechanical strain (driven over high thresholds for doors or elevators), it is possible that one of its main wheel shafts could break because of material fatigue, resulting in the chassis falling on the ground on the affected wheel side. This
FDA root cause category: Device Design
What the company is doing
Siemens sent a Field Safety Notice dated May 2. 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed to : 1) Never step or sit on the unit or otherwise put substantial weight on it. 2) Avoid moving the unit over high thresholds for doors or elevators where possible, or do so carefully and slowly. 3) Make sure that no person had his/her extremities under the chassis, also when the unit is not moving. Update instructions were also released to alert customers of the potential risk and to provide a hardware change which is intended to improve corrosion resistance. An acknowledgement of receipt form was also sent out for the field safety notice and requested to be returned to Siemens. For further questions please call (888) 826-9702.
Recall details
- Recall number
- Z-1875-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 2, 2013
- Posted by the FDA
- Aug 5, 2013
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 39
- Product code
- IZL
- FDA submissions
- K111912
- Distribution
- US Distribution including the states of IA, SD, NC, WI, OH, NE, TX, KS, ID, MI, GA, AR and IL.
Product description
Mobiletta Mira Mobile X-ray System
Code information (models, lots, serial numbers)
Model number 10273100
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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