Device product
Mobilett Mira wireless (VA20) mobile x-ray system(s)
Z-0223-2024
Product summary
- Event
- Event 93304
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4 distributed in U.S.
- Official record key
device-enforcement:Z-0223-2024
Official wording
Reason: 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.
Code information: Model Number 10273100 / UDI 04056869009117 Serial 1511 2168 2525 2633
Distribution pattern: US Nationwide - Worldwide
Derived failure modes
-
Unknown
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.