NMCT 870 DRRecalls & reported problems

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.

20 other recalls cover devices cleared under the same FDA submission (K093514); 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. Feb 7, 2021Open, Classified

   GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.

   Z-1547-2021 · Root cause: Device Design · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093514. One submission often covers many models, so check the product and lot details in each record.

• Z-0893-2025 · Dec 18, 2024 · Open, Classified
  GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2) H2401AK; 3) H2402AC; 4) H3100AH; 5) H3100XB; System, Tomography, Computed, Emission
• Z-0895-2025 · Dec 18, 2024 · Open, Classified
  GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission
• Z-0894-2025 · Dec 18, 2024 · Open, Classified
  GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, Emission
• Z-0891-2025 · Dec 18, 2024 · Open, Classified
  GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401CG, 5) H3100AG, 6) H3100JW, 7) H3100NC; System, Tomography, Co
• Z-1053-2023 · Dec 19, 2022 · Open, Classified
  GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 DR 3/8 inch NM GANTRY WITH NEW ROTOR - MEA, c) 870 DR / Dismount, d) 870 DR / Dismount / 60HZ, e) 870
• Z-0857-2021 · Dec 10, 2020 · Terminated
  Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100XF) - Product Usage: intended for use by
• Z-2997-2020 · Aug 14, 2020 · Terminated
  Discovery NM670 Pro Model # H3100XB
• Z-2996-2020 · Aug 14, 2020 · Terminated
  Discovery 670 DR Model # H3100BT
• Z-2998-2020 · Aug 14, 2020 · Terminated
  NM/CT 870 DR Model # H3100AS
• Z-1259-2019 · Mar 20, 2019 · Terminated
  Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, loca
• Z-1265-2019 · Mar 20, 2019 · Terminated
  NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, di
• Z-1260-2019 · Mar 20, 2019 · Terminated
  Discovery NM/CT 670 ES Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, local
• Z-0607-2019 · May 24, 2018 · Completed
  Discovery NM/CT 670 ES, model 5376204-70-57
• Z-0608-2019 · May 24, 2018 · Completed
  Discovery NM/CT 670 Pro, model 5376204-70-54
• Z-0606-2019 · May 24, 2018 · Completed
  Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalit

…and 5 more.