Recall Z-2308-2025— GE Medical Systems, LLC

Name: FDA recall Z-2308-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-20

Class II · Ongoing

Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2025-06-20. It names one FDA 510(k) clearance: K213668. Product: GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System. Reason: 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
Classification: Class II
Status: Ongoing
Initiated: 2025-06-20
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K213668 — SIGNA HeroGe Healthcare (Ge Medical Systems, LLC)·cleared 2022-01-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GE SIGNA Hero, 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.