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[Recalled] GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System — GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA… | FDA 2025-06-20

recall fda device united-states

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

ProductGE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
Brand / manufacturerGE Medical Systems, LLC
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2301-2025
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date20 June 2025

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from GE Medical Systems, LLC

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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