Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0664-2025 — MICRO-X Rover Mobile X-ray System, # MXU-RV35

U.S. FDA — Device Enforcement · Australia · 2023-05-31 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0664-2025
Date of alert
2023-05-31
Country / jurisdiction
Australia
Risk level
Class II
Risk type
recall
Brand
Micro-X Ltd.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
9357123000037
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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