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, Computed, Emission
type: Dataset
description: FDA recall Z-0891-2025 — GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING is recalling 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, 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/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401CG, 5) H3100AG, 6) H3100JW, 7) H3100NC; System, Tomography, Computed, Emission
  type: MedicalDevice
  manufacturer: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
claims: enforcement-record
claims: FDA classified recall Z-0891-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0891-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0891-2025
      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) 5376204-70-54-2: UDI/DI N/A, System ID NT1030, Serial Number T27G16017/ 133897HL9; UDI/DI N/A, System ID NT4004, Serial Number T27G15008/ 128542HL8; UDI/DI N/A, System ID NT4008, Serial Number T27G16019/ 134674HL1; UDI/DI N/A, System ID NT4007, Serial Number T27G16018/ 134286HL4; UDI/DI N/A, System ID NT4009, Serial Number T27G16016/ 133646HL0; UDI/DI N/A, System ID NT1021, Serial Number T27G1700031/ 147750HL4; UDI/DI N/A, System ID NT4010, Serial Number T27G16020/ 134675HL8; UDI/DI N/A, System ID NT4012, Serial Number T27G1700032/ 148489HL8; UDI/DI N/A, System ID NT4001, Serial Number T27G15002/ 122818HL8; UDI/DI N/A, System ID NT4006, Serial Number T27G15013/ 131436HL8; UDI/DI N/A, System ID NT4002, Serial Number T27G15003/ 124423HL5; UDI/DI N/A, System ID NT4013, Serial Number T27G1700035/ 151334HL0. 2) H2401BC: UDI/DI N/A, System ID 83163862277, Serial Number T2EG1700003/153301HL7; UDI/DI N/A, System ID 83103685384, Serial Number T2AG13029/141BH2; UDI/DI N/A, System ID 83095572309, Serial Number T2AG13023/132BH1; UDI/DI N/A, System ID 83095060278, Serial Number T2AG13025/100091HL8; UDI/DI N/A, System ID 83154010867, Serial Number T2EG1600002/0; UDI/DI N/A, System ID 83091096402, Serial Number T2DG13001/133BH9; UDI/DI N/A, System ID 0910265076, Serial Number T2AG12006/86884HL4; UDI/DI N/A, System ID 0910263259, Serial Number T2AG12010/103BH2; UDI/DI N/A, System ID 0910263259, Serial Number T2AG12014/103BH2; UDI/DI N/A, System ID NT1014, Serial Number T2AG13024/134BH7; UDI/DI N/A, System ID KW1001NM01, Serial Number T2BG12002/319938HM7; UDI/DI N/A, System ID 0834260011, Serial Number T2AG13031/106485HL6; UDI/DI N/A, System ID 0920269097, Serial Number T2AG12015/118BH0; UDI/DI N/A, System ID Not Available, Serial Number T2EG15001; UDI/DI N/A, System ID Not Available, Serial Number T2EG1600001; UDI/DI N/A, System ID Not Available, Serial Number T2EG1700004; UDI/DI N/A, System ID Not Available, Serial Number T2AG12007; UDI/DI N/A, System ID Not Available, Serial N…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-0891-2025: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING is recalling 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, Computed, Emission
text: The FDA logged enforcement record Z-0891-2025: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING is voluntarily recalling 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, 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) 5376204-70-54-2: UDI/DI N/A, System ID NT1030, Serial Number T27G16017/ 133897HL9; UDI/DI N/A, System ID NT4004, Serial Number T27G15008/ 128542HL8; UDI/DI N/A, System ID NT4008, Serial Number T27G16019/ 134674HL1; UDI/DI N/A, System ID NT4007, Serial Number T27G16018/ 134286HL4; UDI/DI N/A, System ID NT4009, Serial Number T27G16016/ 133646HL0; UDI/DI N/A, System ID NT1021, Serial Number T27G1700031/ 147750HL4; UDI/DI N/A, System ID NT4010, Serial Number T27G16020/ 134675HL8; UDI/DI N/A, System ID NT4012, Serial Number T27G1700032/ 148489HL8; UDI/DI N/A, System ID NT4001, Serial Number T27G15002/ 122818HL8; UDI/DI N/A, System ID NT4006, Serial Number T27G15013/ 131436HL8; UDI/DI N/A, System ID NT4002, Serial Number T27G15003/ 124423HL5; UDI/DI N/A, System ID NT4013, Serial Number T27G1700035/ 151334HL0. 2) H2401BC: UDI/DI N/A, System ID 83163862277, Serial Number T2EG1700003/153301HL7; UDI/DI N/A, System ID 83103685384, Serial Number T2AG13029/141BH2; UDI/DI N/A, System ID 83095572309, Serial Number T2AG13023/132BH1; UDI/DI N/A, System ID 83095060278, Serial Number T2AG13025/100091H…
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-0891-2025 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.