Recall
FDAHealthJune 20, 2025

GE Medical Systems, LLC — GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System

⚠️ 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.

Is this relevant to me?

Geography
Unknown
Source agency
FDA
Category
Health
Published
June 20, 2025

Worldwide distribution.

What's affected?

Product
GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System
Lot code
GTIN: 00195278023643, 00840682102704, 00840682102728, 00840682103787, 00840682103817, 00840682123440, Not applicable, Not Available; All System ID numbers that GE HealthCare performed planned maintenance on since March 1, 2023

Additional details

GTIN: 00195278023643, 00840682102704, 00840682102728, 00840682103787, 00840682103817, 00840682123440, Not applicable, Not Available; All System ID numbers that GE HealthCare performed planned maintenance on since March 1, 2023

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 519 units.

View original FDA notice →

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