Mobilett Mira wireless (VA20) mobile x-ray system(s) recallZ-0223-2024 · Siemens Medical Solutions USA, Inc · initiated Oct 5, 2023
Class II Open, Classified All recalls posted in November 2023
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
Due to the incorrect mounting of the buzzer component, there is no acoustic signal during x ray activation. Otherwise, the system is fully functional, and x ray is applied correctly. By means of the additional visual indicator (exposure LED light) the operator can monitor the x ray release. Also, after a successful x ray exposure, the clinical image is displayed on the monitor.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Customer notification by means of a Customer Safety Advisory Notice (via electronic mail or FedEx) alerting customers to the lack of acoustic signal issue and providing instructions to monitor the visual indicator (exposure LED light) to avoid additional, unnecessary x-ray dose. The CSAN also includes the plan for the affected D810 boards. The boards (containing the faulty mounting of the buzzer) will be replaced, free of charge, at the customer site with field corrective action XP042/23/P. There is no software update.
Recall details
- Recall number
- Z-0223-2024
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Oct 5, 2023
- Posted by the FDA
- Nov 14, 2023
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 4 distributed in U.S.
- Product code
- IZL
- FDA submissions
- K111912
- Distribution
- US Nationwide - Worldwide
Product description
Mobilett Mira wireless (VA20) mobile x-ray system(s)
Code information (models, lots, serial numbers)
Model Number 10273100 / UDI 04056869009117 Serial 1511 2168 2525 2633
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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