Siemens Medical Solutions USA, Inc Mobilett Mira wireless (VA20) mobile x-ray system(s) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Mobilett Mira wireless (VA20) mobile x-ray system(s)
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Model Number 10273100 / UDI 04056869009117 Serial 1511 2168 2525 2633
Products Sold
Model Number 10273100 / UDI 04056869009117 Serial 1511 2168 2525 2633
Siemens Medical Solutions USA, Inc is recalling Mobilett Mira wireless (VA20) mobile x-ray system(s) due to Due to the incorrect mounting of the buzzer component, there is no acoustic signal during x ray activation. Otherwise, the system is fully functional,. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Customer notification by means of a Customer Safety Advisory Notice (via electronic mail or FedEx) alerting customers to the lack of acoustic signal issue and providing instructions to monitor the visual indicator (exposure LED light) to avoid additional, unnecessary x-ray dose. The CSAN also includes the plan for the affected D810 boards. The boards (containing the faulty mounting of the buzzer) will be replaced, free of charge, at the customer site with field corrective action XP042/23/P. There is no software update.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026