Z-1669-2025 Class II Ongoing
FDA device recall Z-1669-2025 was initiated by Micro-X Ltd. on Apr 4, 2025 and is designated Class II. Reason for recall: Potential for internal fastening mechanism within generator of mobile x-Ray to fail. The recall status is ongoing. Affected quantity: 13 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 30, 2025
- Initiation Date
- Apr 4, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 units
Product Description
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
Reason for Recall
Potential for internal fastening mechanism within generator of mobile x-Ray to fail.
Distribution Pattern
US: NJ, WA, Puerto Rico OUS: None
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1669-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026