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Siemens Medical Solutions USA, Inc recalls Mobilett Mira wireless (VA20) mobile x-ray system(s)
Recalled November 22, 2023 · FDA recall Z-0223-2024 · Siemens Medical Solutions USA
Hazard
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 Class II
Units
4 distributed in U.S.
Sold at
US Nationwide - Worldwide
Description
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.
Product
Mobilett Mira wireless (VA20) mobile x-ray system(s)
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →