NM 830Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840682140829), received between Dec 10, 2025 and Dec 10, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Misassembled During Installation” (1 report).

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. How this data works · Data updated Oct 13, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2025Misassembled During Installation; Misassembled During Installation

  A GE HEALTHCARE FIELD ENGINEER SUSTAINED A FINGER FRACTURE DURING THE INSTALLATION OF AN 830 TANDEM SYSTEM DETECTOR. THE INJURY OCCURRED WHEN THE ENGINEER LEFT INDEX FINGER BECAME TRAPPED BETWEEN THE GANTRY SWIVEL MECHANISM AND THE DETECTOR WHILE MOVING THE DETECTOR TOWARD THE SWIVEL MECHANISM.

  Patient problems: Bone Fracture(s)

  MAUDE report 23769969 ↗

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