Z-1819-2025.jsonld
type: Dataset
name: OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
description: FDA recall Z-1819-2025 — GE Medical Systems, LLC is recalling OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures. (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: OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
  manufacturer: GE Medical Systems, LLC
claims: enforcement-record
claims: FDA classified recall Z-1819-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1819-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1819-2025
      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: OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2025-03-21
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: Two populations are potentially affected by this notification. 1. Listed in Appendix A - OEC Elite Mobile C-arm Systems (GTIN: 00001234567895) and OEC 3D Mobile C-arm Systems (GTIN: 00195278096944) that potentially have an X-ray field size greater than the 4% SID limit and do not contain the acceptance limit for the X-ray field size measurement in the System Service Manual. 2. Systems NOT listed in Appendix A - OEC Elite Mobile C-arm Systems (GTIN: 00001234567895) and OEC 3D Mobile C-arm Systems (GTIN: 00195278096944) that are within the allowed SID limit. However, the acceptance limit for the X-ray field size measurement is not stated in the System Service Manual. Appendix A Serial Numbers FAHXTX00002 FAHXTX00005 FAHXTX00014 FAHXTX00018 FAHXTX00019 FAHXTX00020 FAHXTX00024 FAHXTX00028 FAHXTX00034 FAHXTX00037 FAHXTX00043 FAHXTX00052 FAHXTX00063 FAHXTX00066 FAHXTX00068 FAHXTX00070 FAHXTX00075 FAHXTX00078 FAHXTX00079 FAHXTX00080 FAHXTX00081 FAHXTX00083 FAHXTX00092 FAHXTX00093 FAHXTX00097 FAHXTX00110 FAHXTX00111 FAHXTX00112 FAHXTX00114 FAHXTX00115 FAHXTX00116 FAHXTX00117 FAHXTX00118 FAHXTX00119 FAHXTX00120 FAHXTX00121 FAHXTX00122 FAHXTX00124 FAHXTX00125 FAHXTX00135 FAHXTX00137 FAHXTX00138 FAHXTX00151 FAHXTX00152 FAHXTX00155 FAHXTX00156 FAHXTX00162 FAHXTX00163 FAHXTX00166 FAHXTX00170 FAHXTX00171 FAHXTX00177 FAHXTX00178 FAHXTX00188 FAHXTX00192 FAHXTX00193 FAHXTX00202 FAHXTX00204 FAHXTX00211 FAHXTX00212 FAHXTX00217 FAHXTX00219 FAHXTX00220 FAHXTX00221 FAHXTX00222 FAHXTX00223 FAHXTX00224 FAHXTX00226 FAHXTX00227 FAHXTX00229 FAHXTX00230 FAHXTX00236 FAHXTX00240 FAHXTX00244 FAHXTX00261 FAHXTX00265 FAHXTX00266 FAHXTX00269 FAHXTX00271 FAHXTX00272 FAHXTX00273 FAHXTX00274 FAHXTX00280 FAHXTX00283 FAHXTX00284 FAHXTX00296 FAHXTX00299 FAHXTX00300 FAHXTX00304 FAHXTX00305 FAHXTX00308 FAHXTX00312 FAHXTX00313 FAHXTX00320 FAHXTX00323 FAHXTX00325 FAHXTX00332 FAHXTX00340 FAHXTX00342 FAHXTX00343 FAHXTX00352 FAHXTX00353 FAHXTX00354 FAHXTX00357 FAHXTX00358 FAHXTX00359 FAHXTX00360 FAHXTX00363 FAHX…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US and OUS
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-1819-2025: GE Medical Systems, LLC is recalling OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
text: The FDA logged enforcement record Z-1819-2025: GE Medical Systems, LLC is recalling (FDA-mandated) OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures. — reason: OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-03-21. Affected lots/codes: Two populations are potentially affected by this notification. 1. Listed in Appendix A - OEC Elite Mobile C-arm Systems (GTIN: 00001234567895) and OEC 3D Mobile C-arm Systems (GTIN: 00195278096944) that potentially have an X-ray field size greater than the 4% SID limit and do not contain the acceptance limit for the X-ray field size measurement in the System Service Manual. 2. Systems NOT listed in Appendix A - OEC Elite Mobile C-arm Systems (GTIN: 00001234567895) and OEC 3D Mobile C-arm Systems (GTIN: 00195278096944) that are within the allowed SID limit. However, the acceptance limit for the X-ray field size measurement is not stated in the System Service Manual. Appendix A Serial Numbers FAHXTX00002 FAHXTX00005 FAHXTX00014 FAHXTX00018 FAHXTX00019 FAHXTX00020 FAHXTX00024 FAHXTX00028 FAHXTX00034 FAHXTX00037 FAHXTX00043 FAHXTX00052 FAHXTX00063 FAHXTX00066 FAHXTX00068 FAHXTX00070 FAHXTX00075 FAHXTX00078 FAHXTX00079 FAHXTX00080 FAHXTX00081 FAHXTX00083 FAHXTX00092 FAHXTX00093 FAHXTX00097 FAHXTX00110 FAHXTX00111 FAHXTX00112 FAHXTX00114 FAHXTX00115 FAHXTX00116 FAHXTX00117 FAHXTX00118 FAHXTX00119 FAHXTX00120 FAHXTX00121 FAHXTX00122 FAHXTX00124 FAHXTX00125 FAHXTX00135 FAHXTX00137 FAHXTX00138 FAHXTX00151 FAHXTX00152 FAHXTX00155 FAHXTX00156 FAHXTX00162 FAHXTX00163 FAHXTX00166 FAHXTX00170 FAHXTX00171 FAHXTX00177 FAHXTX00178 FAHXTX00188 FAHXTX00192 FAHXTX00193 FAHXTX00202 FAHXTX00204 FAHXTX00211 FAHXTX00212 FAHXTX00217 FAHXTX00219 FAHXTX00220 FAHXTX00221 …
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-1819-2025 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.