FDA recall Z-0223-2024

Siemens Medical Solutions USA, Inc · Class II · device

Product

Mobilett Mira wireless (VA20) mobile x-ray system(s)

Reason for recall

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.

Distribution

US Nationwide - Worldwide

Key facts

Status
Ongoing
Initiation date
2023-10-05
Report date
2023-11-22
Voluntary/Mandated
FDA Mandated
Location
Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0223-2024