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Open, Classified

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

FDA Recall Z-0580-2025 · Posted 2024-11-27

Recalling FirmMicro-X Ltd.
Recall StatusOpen, Classified
Product CodeIZL
Date Initiated2024-10-22
Product Quantity6

Reason for Recall

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.

Firm Action

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]

Root Cause

Environmental control

Distribution Pattern

US: TX, PR, MD, 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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