GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5) H3100JY; System, Tomography, Computed, Emission
type: Dataset
description: FDA recall Z-0890-2025 — GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING is recalling GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5) H3100JY; System, Tomography, Computed, Emission (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.
license: https://creativecommons.org/publicdomain/zero/1.0/
is accessible for free: true
is part of: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
is defined by: https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native
see also: https://agenticu.ryanjhunter.workers.dev/commons/the-research-object
date modified: 2026-06-24T07:02:03.626072+00:00
is based on: openFDA drug & device enforcement (recall) reports
  type: Dataset
  creator: U.S. Food & Drug Administration
about: GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5) H3100JY; System, Tomography, Computed, Emission
  type: MedicalDevice
  manufacturer: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
claims: enforcement-record
claims: FDA classified recall Z-0890-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0890-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0890-2025
      status: recorded
  item list element: ListItem
    position: 2
    item:
      field: Product type
      value: Devices
      status: recorded
  item list element: ListItem
    position: 3
    item:
      field: Classification
      value: Class II
      status: determination
  item list element: ListItem
    position: 4
    item:
      field: Status
      value: Ongoing — the recall is still being carried out.
      status: recorded
  item list element: ListItem
    position: 5
    item:
      field: Recalling firm
      value: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: 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.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-12-18
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: 1) 5376204-30-2: UDI/DI N/A, System ID NT3058, Serial Number T2BG1600023/ 146187HL0; UDI/DI N/A, System ID NT3061, Serial Number T2BG1600029/ 147600HL1; UDI/DI N/A, System ID NT3111, Serial Number 147243HL0; UDI/DI N/A, System ID NT3072, Serial Number 151822HL4; UDI/DI N/A, System ID NT3081, Serial Number T2BG1700045/ 155928HL5; UDI/DI N/A, System ID NT3080, Serial Number T2BG1700042/ 155272HL8; UDI/DI N/A, System ID NT3098, Serial Number T2BG1700051/ 158839HL1; UDI/DI N/A, System ID NT3088, Serial Number T2BG1700048/ 157050HL6; UDI/DI N/A, System ID NT3073, Serial Number T2BG1700040/ 150067HL7; UDI/DI N/A, System ID NT3076, Serial Number 153537HL6; UDI/DI N/A, System ID NT3048, Serial Number 141262HL6; UDI/DI N/A, System ID NT3083, Serial Number T2BG1700049/ 158144HL6; UDI/DI N/A, System ID NT0003, Serial Number T2AG14033/ 108281HL7; UDI/DI N/A, System ID NT3064, Serial Number T2BG1600025/ 146380HL1; UDI/DI N/A, System ID NT3082, Serial Number T2BG1700047/ 156900HL3; UDI/DI N/A, System ID NT3057, Serial Number T2BG1600022/ 146064HL1; UDI/DI N/A, System ID NT0005, Serial Number T2AG14040/ 119081HL8; UDI/DI N/A, System ID NT3054, Serial Number T2BG1600019/ 144873HL7; UDI/DI N/A, System ID NT3070, Serial Number T2BG1600024/ 146363HL7; UDI/DI N/A, System ID NT3067, Serial Number T2BG1600031/ 148143HL1; UDI/DI N/A, System ID NT3068, Serial Number T2BG1600034/ 149490HL5; UDI/DI N/A, System ID NT3063, Serial Number T2BG1600030/ 147951HL8; UDI/DI N/A, System ID NT3062, Serial Number T2BG1600033/ 148956HL6; UDI/DI N/A, System ID NT3056, Serial Number T2BG1600020/ 145513HL8; UDI/DI N/A, System ID NT1018, Serial Number T2AG13032/ 107349HL3; UDI/DI N/A, System ID NT3078, Serial Number T2BG1700043/ 155484HL9; UDI/DI N/A, System ID NT3089, Serial Number T2BG1800001/ 159887HL9; UDI/DI N/A, System ID NT3065, Serial Number T2BG1600032/ 148379HL1; UDI/DI N/A, System ID NT3085, Serial Number T2BG1700052/ 158907HL6; UDI/DI N/A, System ID NT3074, Serial Number T2BG1700039/ 151143HL5; U…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-0890-2025: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING is recalling GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5) H3100JY; System, Tomography, Computed, Emission
text: The FDA logged enforcement record Z-0890-2025: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING is voluntarily recalling GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5) H3100JY; System, Tomography, Computed, Emission — reason: 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.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-12-18. Affected lots/codes: 1) 5376204-30-2: UDI/DI N/A, System ID NT3058, Serial Number T2BG1600023/ 146187HL0; UDI/DI N/A, System ID NT3061, Serial Number T2BG1600029/ 147600HL1; UDI/DI N/A, System ID NT3111, Serial Number 147243HL0; UDI/DI N/A, System ID NT3072, Serial Number 151822HL4; UDI/DI N/A, System ID NT3081, Serial Number T2BG1700045/ 155928HL5; UDI/DI N/A, System ID NT3080, Serial Number T2BG1700042/ 155272HL8; UDI/DI N/A, System ID NT3098, Serial Number T2BG1700051/ 158839HL1; UDI/DI N/A, System ID NT3088, Serial Number T2BG1700048/ 157050HL6; UDI/DI N/A, System ID NT3073, Serial Number T2BG1700040/ 150067HL7; UDI/DI N/A, System ID NT3076, Serial Number 153537HL6; UDI/DI N/A, System ID NT3048, Serial Number 141262HL6; UDI/DI N/A, System ID NT3083, Serial Number T2BG1700049/ 158144HL6; UDI/DI N/A, System ID NT0003, Serial Number T2AG14033/ 108281HL7; UDI/DI N/A, System ID NT3064, Serial Number T2BG1600025/ 146380HL1; UDI/DI N/A, System ID NT3082, Serial Number T2BG1700047/ 156900HL3; UDI/DI N/A, System ID NT3057, Serial Number T2BG1600022/ 146064HL1; UDI/DI N/A, System ID NT0005, Serial Number T2AG14040/ 119081HL8; UDI/DI N/A, Sys…
claim type: official_fact
review status: current
commercial influence: false
epistemic status:
  occurred: true
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: SourceCitation
  source: openFDA drug & device enforcement (recall) reports — U.S. FDA
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Devices recall, status Ongoing
  adjudicator: openFDA drug & device enforcement (recall) reports — U.S. FDA
falsifier: A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release.

FDA classified recall Z-0890-2025 as Class II
type: Claim
text: The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.
claim type: regulatory_determination
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: AdjudicativeAct
  source: U.S. FDA recall classification (openFDA enforcement)
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Class II
  adjudicator: U.S. FDA recall classification (openFDA enforcement)
falsifier: occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies.

What an FDA recall is — and is NOT
type: Claim
text: A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.
claim type: interpretation
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: false
  operative: true
grounding:
  grounding type: Interpretation
  source: Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
  source url: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
  value: a recorded enforcement action, not proof of harm or causation; not medical advice
falsifier: occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not.