FDA-Device2023-11-22Class II
Mobilett Mira wireless (VA20) mobile x-ray system(s)
Siemens Medical Solutions USA, Inc
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.
Sold states
US Nationwide - Worldwide
Affected count
4 distributed in U.S.
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Mobilett Mira wireless (VA20) mobile x-ray system(s)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0223-2024Don't want to check this manually?
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