Micro-X Ltd.: Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 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-1578-2025

Recalling firm

Micro-X Ltd.

Product

Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 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

2025-03-28

Posted

2025-04-16

Terminated

not on file

Reason

Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.

Root cause

Device Design

Action

On March 28, 2025, Micro-X Ltd. issued a "Urgent: Medical Device Correction" notification to affected consignees via E-Mail. Micro-X asked consignees to take the following actions: 1. Continue to use your product as normal in accordance with its intended use. 2. Your local service representative will be in contact to apply this update to the systems at the next site visit. 3. Circulate this notice to all users of this device so they are aware of the issue. 4. If the product has been further distributed to other facilities, please ensure this notice is immediately shared with them. 5. Please retain this letter with your system(s) documentation. 6. Please complete and return the attached response form to Micro-X to the Micro-X LTD in Australia: support@micro-x.com and copy djerkovic@micro-x.com.

Quantity

31 units

Distribution

US Nationwide distribution in the states of CA, NJ, and Puerto Rico (US territory).

Lot, serial or model codes

Serial Number/UDI: MSN0334 (01)09357123000051(11)220921(21)00334; MSN0350 (01)09357123000037(11)230328(21)00350 ; MSN0352 (01)09357123000051(11)230823(21)00352; MSN0364 01)09357123000051(11)230705(21)00364; MSN0382 (01)09357123000051(11)230809(21)00382; MSN0383 (01)09357123000051(11)230814(21)00383; MSN0384 (01)09357123000051(11)230816(21)00384; MSN0385 (01)09357123000051(11)230906(21)00385; MSN0386 (01)09357123000051(11)230908(21)00386; MSN0387 (01)09357123000051(11)230914(21)00387; MSN0388 (01)09357123000051(11)230916(21)00388; MSN0389 (01)09357123000051(11)230918(21)00389; MSN0390 (01)09357123000051(11)231013(21)00390; MSN0395 (01)09357123000051(11)231106(21)00395; MSN0397 (01)09357123000051(11)231118(21)00397; MSN0399 (01)09357123000051(11)240122(21)00399; MSN0400 (01)09357123000051(11)240207(21)00400; MSN0401 (01)09357123000051(11)240131(21)00401; MSN0402 01)09357123000051(11)240202(21)00402; MSN0403 (01)09357123000051(11)240205(21)00403; MSN0405 (01)09357123000051(11)240206(21)00405; MSN0408 (01)09357123000051(11)240308(21)00408; MSN0409 (01)09357123000051(11)240312(21)00409; MSN0410 (01)09357123000051(11)240318(21)00410; MSN0411 (01)09357123000051(11)240319(21)00411; MSN0422 (01)09357123000051(11)240724(21)00422; MSN0423 (01)09357123000051(11)240808(21)00423; MSN0424 (01)09357123000051(11)240809(21)00424; MSN0425 (01)09357123000051(11)240812(21)00425; MSN0426 (01)09357123000051(11)240812(21)00426; MSN0427 (01)09357123000051(11)240812(21)00427;

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

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

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