Mobilett Mira wireless (VA20) mobile x-ray system(s)
This recall is currently active, issued November 14, 2023. It was issued by Siemens Medical Solutions Usa, Inc.
- Recall Initiated
- October 5, 2023
- Posted
- November 14, 2023
- Recall Number
- Z-0223-2024
- Quantity
- 4 distributed in U.S.
- Firm Location
- Malvern, PA
- Official Source
- View on FDA website ↗
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
Lot / Code Info
Model Number 10273100 / UDI 04056869009117 Serial 1511 2168 2525 2633
Root Cause
Nonconforming Material/Component
Action Taken
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.