Z-0899-2025.jsonld
type: Dataset
name: GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H2799YC; 4) H2799YD; 5) H3000WC; 6) H3000WD; 7) H3000WT; 8) H3000WW; 9) H3000WY; 10) H3000WZ; System, Tomography, Computed, Emission
description: FDA recall Z-0899-2025 — GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING is recalling GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H2799YC; 4) H2799YD; 5) H3000WC; 6) H3000WD; 7) H3000WT; 8) H3000WW; 9) H3000WY; 10) H3000WZ; 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: MedicalDevice
  name: GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H2799YC; 4) H2799YD; 5) H3000WC; 6) H3000WD; 7) H3000WT; 8) H3000WW; 9) H3000WY; 10) H3000WZ; System, Tomography, Computed, Emission
  manufacturer: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
claims: enforcement-record
claims: FDA classified recall Z-0899-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0899-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0899-2025
      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) H2799PP: UDI/DI N/A, System ID 850260060, Serial Number 16130. 2) H2799PR: UDI/DI N/A, System ID 217347INF2, Serial Number 17325. 3) H2799YC: UDI/DI N/A, System ID M54606103, Serial Number 16846. 4) H2799YD: UDI/DI N/A, System ID M348992912, Serial Number 17033. 5) H3000WC: UDI/DI N/A, System ID 907562HK4, Serial Number 18610; UDI/DI N/A, System ID 907562HK4, Serial Number 18643; UDI/DI N/A, System ID 205783INF1, Serial Number 17571; UDI/DI N/A, System ID 479553INF, Serial Number 18470; UDI/DI N/A, System ID 479441INF1, Serial Number 17301; UDI/DI N/A, System ID 928855INF, Serial Number 17190; UDI/DI N/A, System ID 480512INF1, Serial Number 17019; UDI/DI N/A, System ID 602406INF1, Serial Number 18422; UDI/DI N/A, System ID 602406INF3, Serial Number 18465; UDI/DI N/A, System ID 480323INFRM3, Serial Number 17488; UDI/DI N/A, System ID 480882INF1, Serial Number 18026; UDI/DI N/A, System ID 530888IN1, Serial Number 18579; UDI/DI N/A, System ID 760873NUC, Serial Number 17290; UDI/DI N/A, System ID 6502IN1, Serial Number 17680; UDI/DI N/A, System ID 916537IN2, Serial Number 17264; UDI/DI N/A, System ID 510537IN1, Serial Number 18280; UDI/DI N/A, System ID 626915INF1, Serial Number 16946; UDI/DI N/A, System ID 209223IN, Serial Number 18308; UDI/DI N/A, System ID 559353IN, Serial Number 17995; UDI/DI N/A, System ID 626573INF1, Serial Number 17410; UDI/DI N/A, System ID 510400IN, Serial Number 17108; UDI/DI N/A, System ID 530533IN, Serial Number 18531; UDI/DI N/A, System ID 916782IN1, Serial Number 17973; UDI/DI N/A, System ID 916782IN2, Serial Number 17987; UDI/DI N/A, System ID 916453IN, Serial Number 17373; UDI/DI N/A, System ID 916703IN2, Serial Number 17699; UDI/DI N/A, System ID 916733IN, Serial Number 18460; UDI/DI N/A, System ID 415838IN, Serial Number 17269; UDI/DI N/A, System ID 415353IN2, Serial Number 18305; UDI/DI N/A, System ID 4082IN, Serial Number 17392; UDI/DI N/A, System ID 408315IN, Serial Number 17579; UDI/DI N/A, System ID 408259IN2, Serial Number 186…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-0899-2025: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING is recalling GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H2799YC; 4) H2799YD; 5) H3000WC; 6) H3000WD; 7) H3000WT; 8) H3000WW; 9) H3000WY; 10) H3000WZ; System, Tomography, Computed, Emission
text: The FDA logged enforcement record Z-0899-2025: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING is voluntarily recalling GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H2799YC; 4) H2799YD; 5) H3000WC; 6) H3000WD; 7) H3000WT; 8) H3000WW; 9) H3000WY; 10) H3000WZ; 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) H2799PP: UDI/DI N/A, System ID 850260060, Serial Number 16130. 2) H2799PR: UDI/DI N/A, System ID 217347INF2, Serial Number 17325. 3) H2799YC: UDI/DI N/A, System ID M54606103, Serial Number 16846. 4) H2799YD: UDI/DI N/A, System ID M348992912, Serial Number 17033. 5) H3000WC: UDI/DI N/A, System ID 907562HK4, Serial Number 18610; UDI/DI N/A, System ID 907562HK4, Serial Number 18643; UDI/DI N/A, System ID 205783INF1, Serial Number 17571; UDI/DI N/A, System ID 479553INF, Serial Number 18470; UDI/DI N/A, System ID 479441INF1, Serial Number 17301; UDI/DI N/A, System ID 928855INF, Serial Number 17190; UDI/DI N/A, System ID 480512INF1, Serial Number 17019; UDI/DI N/A, System ID 602406INF1, Serial Number 18422; UDI/DI N/A, System ID 602406INF3, Serial Number 18465; UDI/DI N/A, System ID 480323INFRM3, Serial Number 17488; UDI/DI N/A, System ID 480882INF1, Serial Number 18026; UDI/DI N/A, System ID 530888IN1, Serial Number 18579; UDI/DI N/A, System ID 760873NUC, Serial Number 17290; UDI/DI N/A, System ID 6502IN1, Serial Number 17680; UDI/DI N/A, System ID 916537IN2…
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-0899-2025 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.