GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Computed, Emission
type: Dataset
description: FDA recall Z-0897-2025 — GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING is recalling GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; 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 Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Computed, Emission
  type: MedicalDevice
  manufacturer: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
claims: FDA recall Z-0897-2025: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING is recalling GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Computed, Emission
claims: FDA classified recall Z-0897-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0897-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0897-2025
      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) H2799ZP: UDI/DI N/A, System ID A5109665, Serial Number 16611; 2) H3000WT: UDI/DI N/A, System ID 205408NUC, Serial Number 17419; UDI/DI N/A, System ID 256341NRM1, Serial Number 18226; UDI/DI N/A, System ID 256494NM1, Serial Number 17133; UDI/DI N/A, System ID 256543INF1, Serial Number 17182; UDI/DI N/A, System ID 205408INF2, Serial Number 18157; UDI/DI N/A, System ID 256429INF1, Serial Number 17557; UDI/DI N/A, System ID 256327NUC, Serial Number 17900; UDI/DI N/A, System ID 334418INF, Serial Number 17266; UDI/DI N/A, System ID 256386HKNM2, Serial Number 16970; UDI/DI N/A, System ID 205750INF, Serial Number 16802; UDI/DI N/A, System ID 501776INF, Serial Number 17294; UDI/DI N/A, System ID 479463INF2, Serial Number 16900; UDI/DI N/A, System ID 501202INF, Serial Number 16564; UDI/DI N/A, System ID 479967INF, Serial Number 16817; UDI/DI N/A, System ID 479549INF, Serial Number 18319; UDI/DI N/A, System ID 479751INF, Serial Number 16800; UDI/DI N/A, System ID 928214INF, Serial Number 17075; UDI/DI N/A, System ID 520868INF, Serial Number 18289; UDI/DI N/A, System ID 602588INF, Serial Number 17054; UDI/DI N/A, System ID 623406INF1, Serial Number 17064; UDI/DI N/A, System ID 480512INF2, Serial Number 18250; UDI/DI N/A, System ID 623478NM2, Serial Number 16223; UDI/DI N/A, System ID 602406INF, Serial Number 17739; UDI/DI N/A, System ID 602406OPINF, Serial Number 17746; UDI/DI N/A, System ID 480324INF, Serial Number 17150; UDI/DI N/A, System ID 480323INFRM2, Serial Number 17584; UDI/DI N/A, System ID 480882INF2, Serial Number 17998; UDI/DI N/A, System ID 441236INFINIA, Serial Number 16912; UDI/DI N/A, System ID 925779IN, Serial Number 17618; UDI/DI N/A, System ID 805489INF1, Serial Number 17043; UDI/DI N/A, System ID 6502IN2, Serial Number 17962; UDI/DI N/A, System ID 760452INF1, Serial Number 18399; UDI/DI N/A, System ID 415925INF, Serial Number 16863; UDI/DI N/A, System ID 661949NUC1, Serial Number 17730; UDI/DI N/A, System ID 805737INF1, Serial Number 17772; UDI/DI N/A, S…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

FDA recall Z-0897-2025: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING is recalling GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Computed, Emission
type: Claim
text: The FDA logged enforcement record Z-0897-2025: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING is voluntarily recalling GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; 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) H2799ZP: UDI/DI N/A, System ID A5109665, Serial Number 16611; 2) H3000WT: UDI/DI N/A, System ID 205408NUC, Serial Number 17419; UDI/DI N/A, System ID 256341NRM1, Serial Number 18226; UDI/DI N/A, System ID 256494NM1, Serial Number 17133; UDI/DI N/A, System ID 256543INF1, Serial Number 17182; UDI/DI N/A, System ID 205408INF2, Serial Number 18157; UDI/DI N/A, System ID 256429INF1, Serial Number 17557; UDI/DI N/A, System ID 256327NUC, Serial Number 17900; UDI/DI N/A, System ID 334418INF, Serial Number 17266; UDI/DI N/A, System ID 256386HKNM2, Serial Number 16970; UDI/DI N/A, System ID 205750INF, Serial Number 16802; UDI/DI N/A, System ID 501776INF, Serial Number 17294; UDI/DI N/A, System ID 479463INF2, Serial Number 16900; UDI/DI N/A, System ID 501202INF, Serial Number 16564; UDI/DI N/A, System ID 479967INF, Serial Number 16817; UDI/DI N/A, System ID 479549INF, Serial Number 18319; UDI/DI N/A, System ID 479751INF, Serial Number 16800; UDI/DI N/A, System ID 928214INF, Serial Number 17075; UDI/DI N/A, System ID 520868INF, Serial Number 18289; UDI/DI N/A, System ID 602588INF, Serial Number 17054; UDI/DI N/A, System ID 623406INF1, Serial Number 17064; UDI/DI N/A, Sy…
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-0897-2025 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.