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

Recall Z-2041-2024 — MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MRT-3010 (MEXL-3010), Vantage Galan 3T MRT-3020 (MEXL-3020)

U.S. FDA — Device Enforcement · United States · 2024-05-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2041-2024
Date of alert
2024-05-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Canon Medical System, USA, INC.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04987670103360
Reported risk: The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followed by melting of the cable, ignition, smoke, and fire.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.