—#203872

Product

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

FDA product code: IZL — System, X-Ray, Mobile
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K111912
Affected lot / code info: Model Number 10273100 / UDI 04056869009117 Serial 1511 2168 2525 2633

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: US Nationwide - Worldwide

Timeline

Recall initiated: 2023-10-05
Posted by FDA: 2023-11-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203872. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.