Z-0666-2025Class II

MICRO-X Rover Mobile X-ray System, # MXU-RV19

Name: Z-0666-2025 MICRO-X Rover Mobile X-ray System, # MXU-RV19
Creator: Micro-X Ltd.
Published: 2024-10-23
License: https://open.fda.gov/license/

Micro-X Ltd. / initiated 2024-10-23 / Open, Classified / root cause: design

FDA source

Micro-X Ltd. began a recall of MICRO-X Rover Mobile X-ray System, # MXU-RV19 on 2024-10-23. FDA classified it as Class II and gives the reason as "During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the stowage unit such that it lands on the prep/expose switch, the prep switch can be activated for a...". 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-0666-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-23
Posted: 2024-12-12
Recalling firm: Micro-X Ltd.
Product: MICRO-X Rover Mobile X-ray System, # MXU-RV19
Product code: IZL System, X-Ray, Mobile
Reason for recall: During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the stowage unit such that it lands on the prep/expose switch, the prep switch can be activated for a very short time such that the orange ring of death is displayed in the tube cooling area of the screen. The system then becomes unresponsive to kV/mAs changes, prep/expose presses. The only way to proceed is to suspend the patient, Exit Nexus DR and relogin and continue the exam.
Root cause tag: design
FDA root cause: Device Design
Action: Starting on 10/23/24 Service Bulletin SB002-22 was sent to customers informing them that a field upgrade was released for the installation of an exposure switch holder. Customers were asked to complete and return an acknowledgement response form to [email protected] For further information, contact your local service representative at [email protected], 1-206-249-8764.
Quantity in commerce: 23
Distribution: US Nationwide Distribution: TX, CA, OH, ID, WA, AZ
Product codes and lots: UDI-DI: 09357123000013. Serial Numbers: 262, 274, 320, 329, 237, 269, 271, 290, 292, 307, 310, 311, 312, 321, 322, 323, 327, 330, 331, 332, 333, 234, 266.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0666-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0666-2025	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)