GE Medical Systems, LLC: Medical Device Recall in 2025 - (Recall #: Z-2308-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System

Product Classification:

Class II

Date Initiated: June 20, 2025

Date Posted: August 20, 2025

Recall Number: Z-2308-2025

Event ID: 97187

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.

Status: Ongoing

Product Quantity: 56 units

Code Information:

GTIN: 00195278472083, 00195278486813, 001952784868131, Not Applicable; All System ID numbers that GE HealthCare performed planned maintenance on since March 1, 2023

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated