Z-1669-2025Class II

Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product...

Name: Z-1669-2025 Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product...
Creator: Micro-X Ltd.
Published: 2025-04-04
License: https://open.fda.gov/license/

Micro-X Ltd. / initiated 2025-04-04 / Open, Classified / root cause: design

FDA source

Micro-X Ltd. began a recall of 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... on 2025-04-04. FDA classified it as Class II and gives the reason as "Potential for internal fastening mechanism within generator of mobile x-Ray to fail". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1669-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-04
Posted: 2025-04-24
Recalling firm: Micro-X Ltd.
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
Product code: IZL System, X-Ray, Mobile
Reason for recall: Potential for internal fastening mechanism within generator of mobile x-Ray to fail.
Root cause tag: design
FDA 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: [email protected] and copy [email protected] 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 in commerce: 13 units
Distribution: US: NJ, WA, Puerto Rico OUS: None
Product codes and lots: (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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1669-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1669-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-30	2025-04-24
Z-1670-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-30	2025-04-24

Product code IZL

K211423Class IIRoverMicro-X Limited / cleared 2021-05-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)