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Open, Classified

MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71

FDA Recall Z-0665-2025 · Posted 2024-12-12

Recalling FirmMicro-X Ltd.
Recall StatusOpen, Classified
Product CodeIZL
Date Initiated2023-11-28
Product Quantity18

Reason for Recall

Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.

Firm Action

On 11/28/23 Modification 17 was sent to customers telling them that Control Boards need to be replaced with Control Board PCBA, 12425-04 that will eliminate the issue. For technical assistance contact: [email protected], 1-206-249-8764 Firm asked distributors to do the following: On next visit please confirm that the bulletins were completed and return the documentation.

Root Cause

Device Design

Distribution Pattern

US Nationwide Distribution: NJ, CA, PR

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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