Z-0665-2025Class II

MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71

Name: Z-0665-2025 MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Creator: Micro-X Ltd.
Published: 2023-11-28
License: https://open.fda.gov/license/

Micro-X Ltd. / initiated 2023-11-28 / Open, Classified / root cause: design

FDA source

Micro-X Ltd. began a recall of MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71 on 2023-11-28. FDA classified it as Class II and gives the reason as "Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator". 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-0665-2025
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-28
Posted: 2024-12-12
Recalling firm: Micro-X Ltd.
Product: MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Product code: IZL System, X-Ray, Mobile
Reason for recall: Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.
Root cause tag: design
FDA root cause: Device Design
Action: On 11/28/23 Modification 17 was sent to customers telling them that Control Boards need to be replaced with Control Board PCBA, 12425-04 that will eliminate the issue. For technical assistance contact: [email protected], 1-206-249-8764 Firm asked distributors to do the following: On next visit please confirm that the bulletins were completed and return the documentation.
Quantity in commerce: 18
Distribution: US Nationwide Distribution: NJ, CA, PR
Product codes and lots: MXU-RV35 UDI-DI: 9357123000037 and MXU-RV71 UDI-DI: 935712300005 using Control Board PCBA, 12425-03 (or earlier). Serial Numbers: MSN00334, MSN00348, MSN00349, MSN00351, MSN00352, MSN00361, MSN00364, MSN00365,MSN00382, MSN00383, MSN00384, MSN00385, MSN00386, MSN00387, MSN00388, MSN00390, MSN00391, MSN00395

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0665-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0665-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-18	2024-12-12

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)