Discovery NM 630Recalls & 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.

9 other recalls cover devices cleared under the same FDA submission (K111445); 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. Dec 19, 2022Open, Classified

   A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

   Z-1054-2023 · Root cause: Process control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111445. One submission often covers many models, so check the product and lot details in each record.

• Z-0890-2025 · Dec 18, 2024 · Open, Classified
  GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5) H3100JY; System, Tomography, Computed, Emission
• Z-0856-2021 · Dec 10, 2020 · Terminated
  Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Product Usage: intended for general Nuclear Medicine imaging p
• Z-2994-2020 · Aug 14, 2020 · Terminated
  Discovery NM 630 Model # H3101RH
• Z-2995-2020 · Aug 14, 2020 · Terminated
  NM 830 Model # H3910AC
• Z-1257-2019 · Mar 20, 2019 · Terminated
  Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection
• Z-0367-2014 · Oct 25, 2013 · Terminated
  GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The GE Discovery NMJCT 670 system is a medical tool intended for use by appropriately trained
• Z-1791-2013 · Jun 13, 2013 · Terminated
  Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM 630 system is a medical tool intended for use by appropriate
• Z-0121-2013 · Oct 12, 2012 · Terminated
  GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diag
• Z-1111-2012 · Jan 11, 2012 · Terminated
  GE Discovery NM 630 The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosin