GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
FDA Recall #Z-2301-2025 — Class II — June 20, 2025
Product Description
GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
Reason for Recall
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.
Recalling Firm
GE Medical Systems, LLC — Waukesha, WI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
19 units
Distribution
Worldwide distribution.
Code Information
GTIN: Not available, Not applicable; All System ID numbers that GE HealthCare performed planned maintenance on since March 1, 2023
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated