Discovery 670 DR (UDI 00840682139359)Recalls & 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.

21 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. Dec 18, 2024Open, Classified

   GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

   Z-0892-2025 · Root cause: Package design/selection · 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-0894-2025 · Dec 18, 2024 · Open, Classified
  GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; 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-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-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-1547-2021 · Feb 7, 2021 · Open, Classified
  NM/CT 870 DR Nuclear Medicine / CT Scanners
• 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-2998-2020 · Aug 14, 2020 · Terminated
  NM/CT 870 DR Model # H3100AS
• 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-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-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-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 6 more.