MICRO-X Rover Mobile X-ray System, # MXU-RV19 recallZ-0666-2025 · Micro-X Ltd. · initiated Oct 23, 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
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0666-2025
- Status
- Open, Classified
- Initiated by the company
- Oct 23, 2024
- Posted by the FDA
- Dec 12, 2024
- Recalling firm
- Micro-X Ltd.
- Quantity
- 23
- Product code
- IZL
- FDA submissions
- K211423
- Distribution
- US Nationwide Distribution: TX, CA, OH, ID, WA, AZ
Product description
MICRO-X Rover Mobile X-ray System, # MXU-RV19
Code information (models, lots, serial numbers)
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.
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)2 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)7 recalls0 reports
- Micro-X RoverMicro-X Limited · Solid State X-Ray Imager (Flat Panel/Digital Imager)3 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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