GE Signa Artist, Nuclear Magnetic Resonance Imaging System

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    GTIN: 00840682123129, 00840682146104, 00195278117021, 00840682123457, 00195278126443, 00195278210036, Not available, and Not applicable; All System ID numbers that GE HealthCare performed planned maintenance on since March 1, 2023
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
GE Medical Systems, LLC
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

GE Signa Artist, Nuclear Magnetic Resonance Imaging System

Product Codes/Lot Numbers:

GTIN: 00840682123129, 00840682146104, 00195278117021, 00840682123457, 00195278126443, 00195278210036, Not available, and Not applicable; All System ID numbers that GE HealthCare performed planned maintenance on since March 1, 2023

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2299-2025

Related Recalls

If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use.

Aug 22, 2025 Other Medical Devices Nationwide View Details →