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NA 1.5T EXPRESS COIL - 16E HEAD NECK ARRAYRecalls & reported problems

Ge Healthcare(Tianjin) Company Limited · 1.5T 16 CHANNEL,HEAD NECK ARRAY · Class 2

1 open recall names 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
1

Summary

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

1 FDA recall record name this device's identifier, 1 still open.

6 other recalls cover devices cleared under the same FDA submission (K123417); 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. Jan 31, 2025Open, Classified

    For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.

    Z-1239-2025 · Root cause: Software design · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123417. One submission often covers many models, so check the product and lot details in each record.

  • Z-1240-2025 · Jan 31, 2025 · Open, Classified
    Brivo MR355, NMRI system
  • Z-1241-2025 · Jan 31, 2025 · Open, Classified
    Optima MR360, NMRI system
  • Z-2478-2024 · Jun 14, 2024 · Open, Classified
    Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
  • Z-2477-2024 · Jun 14, 2024 · Open, Classified
    Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
  • Z-0610-2022 · Dec 23, 2021 · Open, Classified
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355/Optima MR360 System, nuclear magnetic resonance imaging system.
  • Z-3021-2017 · May 11, 2017 · Terminated
    Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, a

Other System, nuclear magnetic resonance imaging devices

All System, nuclear magnetic resonance imaging devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.