GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Computed, Emission
type: Dataset
description: FDA recall Z-0896-2025 — GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING is recalling GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; 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 Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Computed, Emission
  type: MedicalDevice
  manufacturer: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
claims: FDA recall Z-0896-2025: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING is recalling GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Computed, Emission
claims: FDA classified recall Z-0896-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0896-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0896-2025
      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) H3100JZ: UDI/DI N/A, System ID UAB640, Serial Number 26139/25146; UDI/DI N/A, System ID 479441N640, Serial Number 26150/25152; UDI/DI N/A, System ID 480BAY640, Serial Number 26195/25195; UDI/DI N/A, System ID 602UACC640, Serial Number 26191/25189; UDI/DI N/A, System ID 520VA640, Serial Number 26329/640V25328; UDI/DI N/A, System ID 530756OPT1, Serial Number ONMW26439/640W25433; UDI/DI N/A, System ID 626359D640, Serial Number 26109/25111; UDI/DI N/A, System ID 858824NM640, Serial Number 26221/25222; UDI/DI N/A, System ID 909558NM640, Serial Number 26297/640V25296; UDI/DI N/A, System ID 949364D640, Serial Number ONMW26437/640W25432; UDI/DI N/A, System ID 510437O640, Serial Number 26199/25203; UDI/DI N/A, System ID 714456OPT1, Serial Number ONMX26520/640X25513; UDI/DI N/A, System ID 916973OPT1, Serial Number ONMW26426/640W25422; UDI/DI N/A, System ID 619543NM640, Serial Number 26281/25276; UDI/DI N/A, System ID 415300OPTIMA, Serial Number ONMX26481/640X25475; UDI/DI N/A, System ID 415353D640, Serial Number 26149/25115; UDI/DI N/A, System ID 415221NM640 , Serial Number ONMY26475/640Y25556; UDI/DI N/A, System ID 408559O640, Serial Number ONMX26529/640X25522; UDI/DI N/A, System ID 650742OPTIMA, Serial Number ONMX26518/640X25509; UDI/DI N/A, System ID 209476OPT1, Serial Number 26338/640V25337; UDI/DI N/A, System ID 310222NM640, Serial Number ONMW26418/640W25413; UDI/DI N/A, System ID 707554OPT1, Serial Number 26140/25145; UDI/DI N/A, System ID 303695NM1, Serial Number ONMW26436/640W25431; UDI/DI N/A, System ID 303498NMOPTIMA, Serial Number ONMX26505/640X25500; UDI/DI N/A, System ID 970298NM2, Serial Number ONMX26539/640X25535; UDI/DI N/A, System ID 970298NM1, Serial Number ONMX26528/640X25521; UDI/DI N/A, System ID 303689O640, Serial Number ONMX26538/640X25533; UDI/DI N/A, System ID 303PAHO640B, Serial Number ONMW26415/640W25414; UDI/DI N/A, System ID 303PAHO640, Serial Number 26318/640V25317; UDI/DI N/A, System ID 203576NM640, Serial Number 26336/640V25335; UDI/DI N/A, …
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide
      status: recorded

FDA recall Z-0896-2025: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING is recalling GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Computed, Emission
type: Claim
text: The FDA logged enforcement record Z-0896-2025: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING is voluntarily recalling GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; 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) H3100JZ: UDI/DI N/A, System ID UAB640, Serial Number 26139/25146; UDI/DI N/A, System ID 479441N640, Serial Number 26150/25152; UDI/DI N/A, System ID 480BAY640, Serial Number 26195/25195; UDI/DI N/A, System ID 602UACC640, Serial Number 26191/25189; UDI/DI N/A, System ID 520VA640, Serial Number 26329/640V25328; UDI/DI N/A, System ID 530756OPT1, Serial Number ONMW26439/640W25433; UDI/DI N/A, System ID 626359D640, Serial Number 26109/25111; UDI/DI N/A, System ID 858824NM640, Serial Number 26221/25222; UDI/DI N/A, System ID 909558NM640, Serial Number 26297/640V25296; UDI/DI N/A, System ID 949364D640, Serial Number ONMW26437/640W25432; UDI/DI N/A, System ID 510437O640, Serial Number 26199/25203; UDI/DI N/A, System ID 714456OPT1, Serial Number ONMX26520/640X25513; UDI/DI N/A, System ID 916973OPT1, Serial Number ONMW26426/640W25422; UDI/DI N/A, System ID 619543NM640, Serial Number 26281/25276; UDI/DI N/A, System ID 415300OPTIMA, Serial Number ONMX26481/640X25475; UDI/DI N/A, System ID 415353D640, Serial Number 26149/25115; UDI/DI N/A, System ID 415221NM640 , Serial Number ONMY26475/640Y25556; UDI/DI N/A, System ID 408559O640, Serial Number ONMX26529/640X25522; UDI/DI N/A,…
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-0896-2025 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.