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

Recall Z-2301-2025 — GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System

U.S. FDA — Device Enforcement · United States · 2025-06-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2301-2025
Date of alert
2025-06-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Medical Systems, LLC
Product category
device
Product type
Devices
Reported risk: GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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