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Open, Classified

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

FDA Recall Z-0664-2025 · Posted 2024-12-12

Recalling FirmMicro-X Ltd.
Recall StatusOpen, Classified
Product CodeIZL
Date Initiated2023-05-31
Product Quantity5

Reason for Recall

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.

Firm Action

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.

Root Cause

Software design

Distribution Pattern

Worldwide and US Nationwide Distribution: NJ, PR, CA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K211423RoverMicro-X Limited · 2021-05-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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