FDA-Device2025-08-20Class II

GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC
Hazard

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.

Sold states
Worldwide distribution.
Affected count
0
Manufactured in
3200 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2318-2025

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief