Z-0664-2025Class II

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

Name: Z-0664-2025 MICRO-X Rover Mobile X-ray System, # MXU-RV35
Creator: Micro-X Ltd.
Published: 2023-05-31
License: https://open.fda.gov/license/

Micro-X Ltd. / initiated 2023-05-31 / Open, Classified / root cause: software

FDA source

Micro-X Ltd. began a recall of MICRO-X Rover Mobile X-ray System, # MXU-RV35 on 2023-05-31. FDA classified it as Class II and gives the reason as "Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0664-2025
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-31
Posted: 2024-12-12
Recalling firm: Micro-X Ltd.
Product: MICRO-X Rover Mobile X-ray System, # MXU-RV35
Product code: IZL System, X-Ray, Mobile
Reason for recall: Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started.
Root cause tag: software
FDA root cause: Software design
Action: The firm will notify consignees using a service bulletin that was already posted. Additionally, the firm will implement a firmware update to extend the timer (4 ms to 10 ms minimum) to ensure even short exposures achieve the necessary image quality for diagnostic use.
Quantity in commerce: 5
Distribution: Worldwide and US Nationwide Distribution: NJ, PR, CA
Product codes and lots: UDI-DI: 9357123000037. Serial Numbers: 00334, 00348, 00349, 00351, 00361.¿

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0664-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0664-2025	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)