Reported Nov 22, 2023 · Ongoing
Mobilett Mira wireless (VA20) mobile x-ray system(s)
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- Mobilett Mira wireless (VA20) mobile x-ray system(s)
- Lot codes and dates
- Model Number 10273100 / UDI 04056869009117 Serial 1511 2168 2525 2633
- Amount recalled
- 4 distributed in U.S.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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