GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
type: Dataset
description: FDA recall Z-0865-2024 — GE HEALTHCARE AUSTRIA GMBH & CO is recalling GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis (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 Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
  type: MedicalDevice
  manufacturer: GE HEALTHCARE AUSTRIA GMBH & CO
claims: FDA recall Z-0865-2024: GE HEALTHCARE AUSTRIA GMBH & CO is recalling GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
claims: FDA classified recall Z-0865-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0865-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0865-2024
      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 HEALTHCARE AUSTRIA GMBH & CO
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: GE HealthCare has become aware of an issue with certain IC9-RS ultrasound probes (see Affected Products List) that can result in a double image artifact creating a ghost image with realistic features. An unrecognized artifact may lead to misdiagnosis.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2023-12-22
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: UDI/DI 00840682105026112303002, Serial Numbers: 1222552WX0, 1263125WX5, 1066771WX5, 1191105WX4, 1098079WX5, 1108318WX5, 1213744WX4, 1101633WX4, 1255114WX9, 1278312WX2, 1148860WX8, 1194288WX5, 1245514WX3, 1260097WX9, 1086878WX4, 1193938WX6, 1214142WX0, 1214224WX6, 1250333WX0, 1148798WX0, 967787WX3, 1240563WX5, 1086837WX0, 1056904WX4, 1240504WX9, 1240523WX9, 1078218WX3, 1164537WX1, 1164543WX9, 1164578WX5, 1165280WX7, 1226207WX7, 1200650WX8, 1204921WX9, 1209228WX4, 1209233WX4, 1209242WX5, 1209249WX0, 1194302WX4, 1083859WX7, 1136238WX1, 1232511WX4, 965764WX4, 1102510WX3, 1231617WX0, 1188541WX5, 1131135WX4, 1101581WX5, 933487WX1, 1089751WX0, 1094081WX5, 1244833WX8, 1265068WX5, 1191119WX5, 1083721WX9, 1086810WX7, 1089907WX8, 1123486WX1, 1131088WX5, 1131146WX1, 1269644WX9, 1240005WX7, 1240010WX7, 1263059WX6, 1269523WX5, 1057273WX3, 933496WX2, 1213935WX8, 1269599WX5, 1123553WX8, 1131123WX0, 1164520WX7, 1164581WX9, 1148835WX0, 1250262WX1, 1250264WX7, 1263106WX5, 990735WX3, 1191069WX2, 1194282WX8, 1143351WX3, 1089877WX3, 1089885WX6, 1278241WX3, 1278465WX8, 1159170WX8, 1179177WX9, 1188568WX8, 1209245WX8, 1108449WX8, 1164534WX8, 1164565WX2, 1269539WX1, 1226217WX6, 962655WX7, 1191100WX5, 1240408WX3, 1263093WX5, 1035106WX2, 1194124WX2, 1209205WX2, 1214218WX8, 1274014WX8, 1143364WX6, 1214050WX5, 1098089WX4, 1102447WX8, 1102475WX9, 1097980WX5, 1098057WX1, 1098090WX2, 1098138WX9, 1098168WX6, 1240462WX0, 1086887WX5, 1086895WX8, 1131110WX7, 1131120WX6, 1158860WX5, 1158865WX4, 1244831WX2, 1263118WX0, 1148851WX7, 1165397WX9, 1165312WX8, 1148907WX7, 1025662WX6, 1148803WX8, 1148813WX7, 1148815WX2, 1154522WX5, 1101568WX2, 1101607WX8, 1165305WX2, 1123102WX4, 1086846WX1, 1086866WX9, 1060874WX3, 1244827WX0, 1132800WX2, 1135901WX5, 1154449WX1, 1123090WX1, 1159352WX2, 1229720WX6, 1148876WX4, 1240444WX8, 1101601WX1, 1194066WX5, 1131118WX0, 1086834WX7, 1226186WX3, 1229869WX1, 1274044WX5, 1274052WX8, 1025569WX3, 967727WX9, 967750WX1, 1229776WX8, 1244854WX4, 1255316WX0, 1255329WX3, 1101600WX3, 1232…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: worldwide
      status: recorded

FDA recall Z-0865-2024: GE HEALTHCARE AUSTRIA GMBH & CO is recalling GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
type: Claim
text: The FDA logged enforcement record Z-0865-2024: GE HEALTHCARE AUSTRIA GMBH & CO is voluntarily recalling GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis — reason: GE HealthCare has become aware of an issue with certain IC9-RS ultrasound probes (see Affected Products List) that can result in a double image artifact creating a ghost image with realistic features. An unrecognized artifact may lead to misdiagnosis.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-12-22. Affected lots/codes: UDI/DI 00840682105026112303002, Serial Numbers: 1222552WX0, 1263125WX5, 1066771WX5, 1191105WX4, 1098079WX5, 1108318WX5, 1213744WX4, 1101633WX4, 1255114WX9, 1278312WX2, 1148860WX8, 1194288WX5, 1245514WX3, 1260097WX9, 1086878WX4, 1193938WX6, 1214142WX0, 1214224WX6, 1250333WX0, 1148798WX0, 967787WX3, 1240563WX5, 1086837WX0, 1056904WX4, 1240504WX9, 1240523WX9, 1078218WX3, 1164537WX1, 1164543WX9, 1164578WX5, 1165280WX7, 1226207WX7, 1200650WX8, 1204921WX9, 1209228WX4, 1209233WX4, 1209242WX5, 1209249WX0, 1194302WX4, 1083859WX7, 1136238WX1, 1232511WX4, 965764WX4, 1102510WX3, 1231617WX0, 1188541WX5, 1131135WX4, 1101581WX5, 933487WX1, 1089751WX0, 1094081WX5, 1244833WX8, 1265068WX5, 1191119WX5, 1083721WX9, 1086810WX7, 1089907WX8, 1123486WX1, 1131088WX5, 1131146WX1, 1269644WX9, 1240005WX7, 1240010WX7, 1263059WX6, 1269523WX5, 1057273WX3, 933496WX2, 1213935WX8, 1269599WX5, 1123553WX8, 1131123WX0, 1164520WX7, 1164581WX9, 1148835WX0, 1250262WX1, 1250264WX7, 1263106WX5, 990735WX3, 1191069WX2, 1194282WX8, 1143351WX3, 1089877WX3, 1089885WX6, 1278241WX3, 1278465WX8, 1159170WX8, 1179177WX9, 1188568WX8, 1209245WX8, 1108449WX8, 1164534WX8, 1164565WX2, 1269539WX1, 1226217WX6, 962655WX7, 1191100WX5, 1240408WX3, 1263093WX5, 1035106WX2, 1194124WX2, 1209205WX2, 1214218WX8, 1274014WX8, 1143364WX6, 1214050WX5, 1098089WX4, 1102447WX8, 1102475WX9, 1097980WX5, 1098057WX1, 1098090WX2, 1098138WX9, 1098168WX6, 1240462WX0, 10868…
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-0865-2024 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.