MICRO-X Rover Mobile X-ray System, # MXU-RV35 recallZ-0580-2025 · Micro-X Ltd. · initiated Oct 22, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Micro-X Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Environmental control
What the company is doing
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]
Recall details
- Recall number
- Z-0580-2025
- Status
- Open, Classified
- Initiated by the company
- Oct 22, 2024
- Posted by the FDA
- Nov 27, 2024
- Recalling firm
- Micro-X Ltd.
- Quantity
- 6
- Product code
- IZL
- FDA submissions
- K211423
- Distribution
- US: TX, PR, MD, CA
Product description
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Code information (models, lots, serial numbers)
UDI-DI: 9357123000037, Serial Numbers: 348, 349, 361, 351, 365, 391
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Micro-X RoverMicro-X Limited · Solid State X-Ray Imager (Flat Panel/Digital Imager)7 recalls0 reports
Other devices under the same FDA submission
2 devices cleared under K211423 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Micro-X RoverMicro-X Limited · Solid State X-Ray Imager (Flat Panel/Digital Imager)3 recalls0 reports
- Micro-X RoverMicro-X Limited · Solid State X-Ray Imager (Flat Panel/Digital Imager)2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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