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

Recall Z-0665-2025 — MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71

U.S. FDA — Device Enforcement · Australia · 2023-11-28 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0665-2025
Date of alert
2023-11-28
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: Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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