The Recall Desk
Severity pendingFDA (Devices)·Z-2308-2025·Announced 2025-08-20

GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System

Pending LLM rewrite. Source: FDA_DEVICE Z-2308-2025.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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.

The recalled product

Product
GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • GTIN: 00195278472083
  • 00195278486813
  • 001952784868131
  • Not Applicable
  • 2023

Distribution

Distribution scope not specified by the agency.

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