Siemens Mobilette Mira, intended use as Mobile x-ray system recallZ-0480-2013 · Siemens Medical Solutions USA, Inc · initiated Oct 10, 2012
Class II Terminated All recalls posted in December 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
There is a risk of lost images during examination.
FDA root cause category: Software design
What the company is doing
The firm initiated their recall/correction of this product on September 9, 2012 by sending a Field Safety Notification letter with Update Instruction XP054/12/S to all consignees. The letter described the steps to be taken to avoid the potential risk and included a response form to be returned to the recalling firm.
Recall details
- Recall number
- Z-0480-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 10, 2012
- Posted by the FDA
- Dec 6, 2012
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 21
- Product code
- IZL
- FDA submissions
- K111912
- Distribution
- Nationwide distribution: USA including states of: GA, ID, IL, IA, NE, NC, OH, SD, TX, and WI.
Product description
Siemens Mobilette Mira, intended use as 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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