D630 Upgrade H2401XFRecalls & 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.

10 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 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-0889-2025 · Root cause: Package design/selection · 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-1054-2023 · Dec 19, 2022 · Open, Classified
  GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 / 5842894-20, e) 830 / Dismount / 50HZ, f) 830 / Dismount / 60HZ, g) 8
• 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