NA SIGNA Artist (UDI 00840682123129)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840682123129), received between Nov 8, 2024 and Nov 8, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

5 FDA recall records name this device's identifier, 5 still open.

36 other recalls cover devices cleared under the same FDA submission (K160618); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 20, 2025Class IIOpen, Classified

   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.

   Z-2299-2025 · Root cause: Equipment maintenance · Recall details · FDA record ↗

2. Jun 20, 2025Class IIOpen, Classified

   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.

   Z-2303-2025 · Root cause: Equipment maintenance · Recall details · FDA record ↗

3. Jun 20, 2025Class IIOpen, Classified

   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.

   Z-2306-2025 · Root cause: Equipment maintenance · Recall details · FDA record ↗

4. Jun 20, 2025Class IIOpen, Classified

   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.

   Z-2310-2025 · Root cause: Equipment maintenance · Recall details · FDA record ↗

5. Jun 20, 2025Class IIOpen, Classified

   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.

   Z-2302-2025 · Root cause: Equipment maintenance · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT FELT "INTENSE AND STRONG HEAT" ON THEIR RIGHT SIDE DURING A MR EXAMINATION OF THE RIGHT SHOULDER. THERE IS NO REPORT OF A BURN OR OTHER TYPICAL SIGN OF SIGNIFICANT RF-RELATED INJURY. THIS EVENT WAS INITIALLY ASSESSED AS NOT REPORTABLE AS WARMING DURING AN MR EXAM MAY OCCUR DUE TO THE RF ENERGY, AND TYPICALLY RESULTS IN MINOR DISCOMFORT WHICH IS SELF-RESOLVING. SUBSEQUENTLY, THE GE HEALTHCARE COMPLAINT HANDLING UNIT BECAME AWARE OF ADDITIONAL INFORMATION FROM THE PATIENT THAT DESCRIBES ONGOING PAIN THAT REQUIRES PAIN MEDICATION; THEREFORE, WE HAVE UPDATED OUR ASSESSMENT TO A SERIOUS INJURY. THE CAUSE OR SOURCE OF THE ONGOING PAIN HAS NOT BEEN CLEARLY IDENTIFIED. BASED ON THE SERVICE AND PREVENTATIVE MAINTENANCE RECORDS THAT WE HAVE REVIEWED FOR THE SYSTEM FROM THE TIME OF THE EVENT UNTIL NOW, WE DO NOT HAVE ANY EVIDENCE THAT THE SYSTEM MALFUNCTIONED, HOWEVER OUR INVESTIGATION IS ONGOING.

  Patient problems: Pain

  MAUDE report 20643359 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160618. One submission often covers many models, so check the product and lot details in each record.

• Z-2301-2025 · Jun 20, 2025 · Open, Classified
  GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
• Z-2130-2025 · May 23, 2025 · Open, Classified
  SIGNA Architect
• Z-0518-2025 · Oct 28, 2024 · Open, Classified
  SIGNA Architect, Nuclear Magnetic Resonance Imaging System
• Z-0519-2025 · Oct 28, 2024 · Open, Classified
  SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
• Z-0517-2025 · Oct 28, 2024 · Open, Classified
  Discovery MR750w 3.0T, whole body magnetic resonance scanner
• Z-2459-2024 · Jun 14, 2024 · Open, Classified
  SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1, DV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging
• Z-2467-2024 · Jun 14, 2024 · Open, Classified
  Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuclear Magnetic Resonance Imaging System
• Z-2465-2024 · Jun 14, 2024 · Open, Classified
  Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.5, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
• Z-2464-2024 · Jun 14, 2024 · Open, Classified
  Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.4, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
• Z-2468-2024 · Jun 14, 2024 · Open, Classified
  Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
• Z-2469-2024 · Jun 14, 2024 · Open, Classified
  SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
• Z-0593-2022 · Dec 23, 2021 · Open, Classified
  GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w 3.0T System, nuclear magnetic resonance imaging system.
• Z-0591-2022 · Dec 23, 2021 · Open, Classified
  GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect system, nuclear magnetic resonance imaging system.
• Z-0602-2022 · Dec 23, 2021 · Open, Classified
  GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T system, nuclear magnetic resonance imaging system.
• Z-0594-2022 · Dec 23, 2021 · Open, Classified
  GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T System, nuclear magnetic resonance imaging system.

…and 21 more.