MICRO-X Rover Mobile X-ray System, # MXU-RV35 recallZ-0664-2025 · Micro-X Ltd. · initiated May 31, 2023
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
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.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-0664-2025
- Status
- Open, Classified
- Initiated by the company
- May 31, 2023
- Posted by the FDA
- Dec 12, 2024
- Recalling firm
- Micro-X Ltd.
- Quantity
- 5
- Product code
- IZL
- FDA submissions
- K211423
- Distribution
- Worldwide and US Nationwide Distribution: NJ, PR, CA
Product description
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Code information (models, lots, serial numbers)
UDI-DI: 9357123000037. Serial Numbers: 00334, 00348, 00349, 00351, 00361.¿
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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