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NA 5767030-2Recalls & reported problems

GE Medical Systems, L.L.C. · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

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

2 FDA recall records name this device's identifier, 2 still open.

38 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. How this data works · Data updated Oct 13, 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-2299-2025 · Root cause: Equipment maintenance · 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-2302-2025 · Root cause: Equipment maintenance · FDA record ↗

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-2306-2025 · Jun 20, 2025 · Open, Classified
    GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System
  • Z-2301-2025 · Jun 20, 2025 · Open, Classified
    GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
  • Z-2303-2025 · Jun 20, 2025 · Open, Classified
    GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System
  • Z-2130-2025 · May 23, 2025 · Open, Classified
    SIGNA Architect
  • 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-0518-2025 · Oct 28, 2024 · Open, Classified
    SIGNA Architect, 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-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-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-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-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-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.

…and 23 more.

Other System, nuclear magnetic resonance imaging devices

All System, nuclear magnetic resonance imaging devices →

Sources and updates

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