Z-1918-2026Class II

Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71

Name: Z-1918-2026 Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
Creator: Micro-X Ltd.
Published: 2026-03-27
License: https://open.fda.gov/license/

Micro-X Ltd. / initiated 2026-03-27 / Open, Classified / root cause: design

FDA source

Micro-X Ltd. began a recall of Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71 on 2026-03-27. FDA classified it as Class II and gives the reason as "X-Ray generator may malfunction resulting in the X-Ray being inoperable". 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-1918-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-27
Posted: 2026-04-22
Recalling firm: Micro-X Ltd.
Product: Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
Product code: IZL System, X-Ray, Mobile
Reason for recall: X-Ray generator may malfunction resulting in the X-Ray being inoperable.
Root cause tag: design
FDA root cause: Component design/selection
Action: On March 27, 2026, Micro-X issued a Urgent: Medical Device Correction Notification, via E-Mail. Micro-X ask consignees to take the following actions: " Contact your local service representative to arrange replacement of the PCBA with the updated version at the next scheduled visit or Preventative Maintenance. In the interim, customers may continue to use the device. " To minimize the likelihood of system failure, the batteries should not be permitted to fully discharge. Any system errors or abnormal behaviours must be reported to your authorised service provider without delay. " If the product has been further distributed to other facilities, please ensure this notice is immediately shared with them. " Please complete and email the Customer Response Form in Appendix 1 to the Micro-X LTD in Australia: [email protected] and copy [email protected] Completing this form confirms receipt of this notice, understanding of the issue, and the necessary actions to be taken.
Quantity in commerce: 32 units
Distribution: US Nationwide distribution in the states and territories of WA, NJ, CA, Puerto Rico.
Product codes and lots: Lot Code: Refer to product traceability spreadsheet provided MXU-RV71 UDI: (01)09357123000051/ Serial Numbers: 334 397 399 408 423 425 459 MXU-RV35 UDI: (01)09357123000037/ Serial Numbers: 269 223 349 348 351 363 388 384 391 359 416 419 428 429 430 431 435 434 436 413 437 438 460 461 462

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1918-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1918-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22

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)