RecallRadar

FDA Device recall Z-0223-2024

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

On 2023-11-22 the FDA classified a Class II recall of Mobilett Mira wireless (VA20) mobile x-ray system(s) by Siemens Medical Solutions Usa, citing 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 correct….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0223-2024
ClassificationClass II
Statusongoing
Initiated2023-10-05
Published2023-11-22
Last updated2026-09-13 11:56 UTC
CompanySiemens Medical Solutions Usa
DistributionUS

Product

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

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.

Identifiers

code_infoModel Number 10273100 / UDI 04056869009117 Serial 1511 2168 2525 2633

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0223-2024%22

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