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Recall Observatory FDA recall evidence

Device product

Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: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-1670-2025

April 04, 2025

Class II

Product summary

Firm
Micro-X Ltd.
Event
Event 96638
Status
Ongoing
Classification
Class II
Quantity
5 units
Official record key
device-enforcement:Z-1670-2025

Official wording

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

Code information: Serial Number/UDI-DI - 349 (01)09357123000037(11)230209(21)00349 348 (01)09357123000037(11)230123(21)00348 350 (01)09357123000037(11)230328(21)00350. 351 (01)09357123000037(11)230413(21)00351 361 (01)09357123000037(11)230503(21)00361

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.