GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed
type: Dataset
description: FDA recall Z-1298-2025 — GE Medical Systems, LLC is recalling GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed (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 Revolution Apex Elite, System, X-ray, Tomography, Computed
  type: MedicalDevice
  manufacturer: GE Medical Systems, LLC
claims: FDA recall Z-1298-2025: GE Medical Systems, LLC is recalling GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed
claims: FDA classified recall Z-1298-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1298-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1298-2025
      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, LLC
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2025-02-18
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: System ID Number 907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN; System ID Number 256265STCT, UDI (01)00195278460271(11)230600(21)REV2X2300021CN, Mfg. Lot/Serial Number REV2X2300021CN; System ID Number 480342APEX1, UDI (01)00195278460271(11)240600(21)REV2X2400065CN, Mfg. Lot/Serial Number REV2X2400065CN; System ID Number 480342APEX3, UDI (01)00195278460271(11)240600(21)REV2X2400067CN, Mfg. Lot/Serial Number REV2X2400067CN; System ID Number 949250APEX, UDI (01)00195278460271(11)230500(21)REV2X2300008CN, Mfg. Lot/Serial Number REV2X2300008CN; System ID Number 858824REV, UDI (01)00195278460271(11)241100(21)REV2X2400147CN, Mfg. Lot/Serial Number REV2X2400147CN; System ID Number 707257APEX1, UDI (01)00195278460271(11)231000(21)REV2X2300077CN, Mfg. Lot/Serial Number REV2X2300077CN; System ID Number 714456APEX, UDI (01)00195278460271(11)231200(21)REV2X2300094CN, Mfg. Lot/Serial Number REV2X2300094CN; System ID Number 719227APEX1, UDI (01)00195278460271(11)240200(21)REV2X2400019CN, Mfg. Lot/Serial Number REV2X2400019CN; System ID Number 970945CT, UDI (01)00195278460271(11)240400(21)REV2X2400046CN, Mfg. Lot/Serial Number REV2X2400046CN; System ID Number 203576EDAPEX, UDI (01)00195278460271(11)240300(21)REV2X2400021CN, Mfg. Lot/Serial Number REV2X2400021CN; System ID Number 860224EDAPEX, UDI (01)00195278460271(11)240500(21)REV2X2400050CN, Mfg. Lot/Serial Number REV2X2400050CN; System ID Number 203276APEX1, UDI (01)00195278460271(11)240800(21)REV2X2400095CN, Mfg. Lot/Serial Number REV2X2400095CN; System ID Number 302744APEX, UDI (01)00195278460271(11)240600(21)REV2X2400078CN, Mfg. Lot/Serial Number REV2X2400078CN; System ID Number 561737APEX1, UDI (01)00195278460271(11)240900(21)REV2X2400114CN, Mfg. Lot/Serial Number REV2X2400114CN; System ID Number 561737APEX2, UDI (01)00195278460271(11)240900(21)REV2X2400112CN, Mfg. Lot/Serial Number REV2X2400112CN; System ID Number 786243APEX1, UDI (01)00195278460271(11)230900(21)REV2X…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide distribution.
      status: recorded

FDA recall Z-1298-2025: GE Medical Systems, LLC is recalling GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed
type: Claim
text: The FDA logged enforcement record Z-1298-2025: GE Medical Systems, LLC is voluntarily recalling GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed — reason: GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-02-18. Affected lots/codes: System ID Number 907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN; System ID Number 256265STCT, UDI (01)00195278460271(11)230600(21)REV2X2300021CN, Mfg. Lot/Serial Number REV2X2300021CN; System ID Number 480342APEX1, UDI (01)00195278460271(11)240600(21)REV2X2400065CN, Mfg. Lot/Serial Number REV2X2400065CN; System ID Number 480342APEX3, UDI (01)00195278460271(11)240600(21)REV2X2400067CN, Mfg. Lot/Serial Number REV2X2400067CN; System ID Number 949250APEX, UDI (01)00195278460271(11)230500(21)REV2X2300008CN, Mfg. Lot/Serial Number REV2X2300008CN; System ID Number 858824REV, UDI (01)00195278460271(11)241100(21)REV2X2400147CN, Mfg. Lot/Serial Number REV2X2400147CN; System ID Number 707257APEX1, UDI (01)00195278460271(11)231000(21)REV2X2300077CN, Mfg. Lot/Serial Number REV2X2300077CN; System ID Number 714456APEX, UDI (01)00195278460271(11)231200(21)REV2X2300094CN, Mfg. Lot/Serial Number REV2X2300094CN; System ID Number 719227APEX1, UDI (01)00195278460271(11)240200(21)REV2X2400019CN, Mfg. Lot/Serial Number REV2X2400019CN; System ID Number 970945CT, UDI (01)00195278460271(11)240400(21)REV2X2400046CN, Mfg. Lot/Serial Number REV2X2400046CN; System ID Number 203576EDAPEX, UDI (01)0019527846…
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-1298-2025 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.