NA SIGNA Architect (UDI 00840682147095)Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

4 FDA recall records name this device's identifier, 4 still open.

33 other recalls cover devices cleared under the same FDA submission (K163331, K202966); 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 16, 2026.

Recalls naming this device

1. Jun 20, 2025Open, 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 ↗

2. Jun 20, 2025Open, 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 ↗

3. May 23, 2025Open, Classified

   GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.

   Z-2130-2025 · Root cause: Device Design · Recall details · FDA record ↗

4. Oct 28, 2024Open, Classified

   Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.

   Z-0518-2025 · Root cause: Device Design · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163331, K202966. One submission often covers many models, so check the product and lot details in each record.

• Z-2306-2025 · Jun 20, 2025 · Open, Classified
  GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System
• Z-2302-2025 · Jun 20, 2025 · Open, Classified
  GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
• Z-2299-2025 · Jun 20, 2025 · Open, Classified
  GE Signa Artist, Nuclear Magnetic Resonance Imaging System
• Z-2301-2025 · Jun 20, 2025 · Open, Classified
  GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
• Z-0517-2025 · Oct 28, 2024 · Open, Classified
  Discovery MR750w 3.0T, whole body magnetic resonance scanner
• Z-0519-2025 · Oct 28, 2024 · Open, Classified
  SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
• 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-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-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-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-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-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-0600-2022 · Dec 23, 2021 · Open, Classified
  GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist 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 18 more.