Z-0580-2025Class II

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

Name: Z-0580-2025 MICRO-X Rover Mobile X-ray System, # MXU-RV35
Creator: Micro-X Ltd.
Published: 2024-10-22
License: https://open.fda.gov/license/

Micro-X Ltd. / initiated 2024-10-22 / Open, Classified / root cause: manufacturing process

FDA source

Micro-X Ltd. began a recall of MICRO-X Rover Mobile X-ray System, # MXU-RV35 on 2024-10-22. FDA classified it as Class II and gives the reason as "Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation dry time, Atmospheric Pressure:50kPa to 106 kPa(70kPa to...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0580-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-22
Posted: 2024-11-27
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: Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation dry time, Atmospheric Pressure:50kPa to 106 kPa(70kPa to 106kPa), Altitude:-102ft to 12,000 ft, (Maximum Gradient:9 degrees Fahrenheit), which mitigate risk of capacitor malfunction, unpredictable behavior, overheating, unintended start-up.
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: On 10/22/24, Service Bulletin SB007-23-1.0 was emailed to customers restating receiving, storage, and operation conditions and informing customers that extreme humidity environments can adversely affect the equipment. For further information contact your local service representative: phone: 1-206-249-8764 Email: [email protected]
Quantity in commerce: 6
Distribution: US: TX, PR, MD, CA
Product codes and lots: UDI-DI: 9357123000037, Serial Numbers: 348, 349, 361, 351, 365, 391

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0580-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0580-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-27

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)