FDA Medical Device Recalls (openFDA)
Micro-X Ltd.: 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
- Recall number
- Z-1670-2025
- Recalling firm
- Micro-X Ltd.
- 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
- Status
- Open, Classified
- Initiated
- 2025-04-04
- Posted
- 2025-04-24
- Terminated
- not on file
- Reason
- Potential for internal fastening mechanism within generator of mobile x-Ray to fail.
- Root cause
- Device Design
- Action
- On April 4, 2025, Micro-X Ltd. issued a "Urgent Medical Device Correction" Notification to via E-Mail affected consignees. Micro-X ask consignees to take the following actions: " Inspect your stock immediately and quarantine affected stock on hand to prevent further use. " Circulate this notice to all users of this device so they are aware of the issue. " If the product has been further distributed to other facilities, please ensure this notice is immediately shared with them. " Please retain this letter with your system(s) documentation. " Please complete and return the attached response form to the Micro-X LTD in Australia: support@micro-x.com and copy djerkovic@micro-x.com to reconcile this process no later than 30 days from receipt. Completing this form confirms receipt of this notice, understanding of the issue, and the necessary actions to be taken.
- Quantity
- 5 units
- Distribution
- US: NJ, WA, Puerto Rico OUS: None
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K211423"]
- PMA numbers
- not on file
- Product code
- IZL
- Firm FEI
- 3012855798
- Firm city
- Tonsley
- Firm state
- not on file
- Firm country
- Australia
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28