Skip to content
Recall Observatory FDA recall evidence

Device product

Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

Z-1669-2025

April 04, 2025

Class II

Product summary

Firm
Micro-X Ltd.
Event
Event 96638
Status
Ongoing
Classification
Class II
Quantity
13 units
Official record key
device-enforcement:Z-1669-2025

Official wording

Reason: Potential for internal fastening mechanism within generator of mobile x-Ray to fail.

Code information: (Serial Number UDI-DI) 352 (01)09357123000051(11)230823(21)00352 334 (01)09357123000051(11)220921(21)00334 389 (01)09357123000051(11)230814(21)00383 383 (01)09357123000051(11)230814(21)00383 384 (01)09357123000051(11)230816(21)00384 382 (01)09357123000051(11)230809(21)00382 386 (01)09357123000051(11)230908(21)00386 385 (01)09357123000051(11)230906(21)00385 387 (01)09357123000051(11)230914(21)00387 388 (01)09357123000051(11)230916(21)00388 364 01)09357123000051(11)230705(21)00364 390 (01)09357123000051(11)231013(21)00390 395 (01)09357123000051(11)231106(21)00395

Distribution pattern: US: NJ, WA, Puerto Rico OUS: None

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for internal fastening mechanism within generator of mobile x-Ray to fail.