Z-1555-2025.jsonld
type: Dataset
name: Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG, H45135VGW), R3 Surgery for China (Model Number H45113VGSU), R3 PeriOP for China (Model Number H45113VGPO), R3 Expert for China (Model Number H45113VGEX ), R3 Pro for China (Model Number H45113VGPR), R3 Performance for China, R3 Intervention for China, R3 Surgery for China (Model Number H45113VGSU) diagnostic ultrasound systems
description: FDA recall Z-1555-2025 — GE Medical Systems, LLC is recalling Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG, H45135VGW), R3 Surgery for China (Model Number H45113VGSU), R3 PeriOP for China (Model Number H45113VGPO), R3 Expert for China (Model Number H45113VGEX ), R3 Pro for China (Model Number H45113VGPR), R3 Performance for China, R3 Intervention for China, R3 Surgery for China (Model Number H45113VGSU) diagnostic ultrasound systems (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: Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG, H45135VGW), R3 Surgery for China (Model Number H45113VGSU), R3 PeriOP for China (Model Number H45113VGPO), R3 Expert for China (Model Number H45113VGEX ), R3 Pro for China (Model Number H45113VGPR), R3 Performance for China, R3 Intervention for China, R3 Surgery for China (Model Number H45113VGSU) diagnostic ultrasound systems
  manufacturer: GE Medical Systems, LLC
claims: enforcement-record
claims: FDA classified recall Z-1555-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1555-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1555-2025
      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: The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2025-03-06
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: UDI-DI: Venue Go R2 system (GTIN 00840682138840); Venue Go R3 system (GTIN 00840682190503 / GTIN 00195278358011); Venue Go R4 system (GTIN 00195278516510 / GTIN 00195278516527); Venue Go R3 Surgery for China (GTIN 00195278547866) Venue Go R3 PeriOP for China (GTIN 00195278548344) Venue Go R3 Expert for China (GTIN 00195278547262) Venue Go R3 Pro for China (GTIN 00195278547828) Venue Go R3 Performance for China (GTIN 00195278547842) Venue Go R3 Intervention for China (GTIN 00195278548061) Venue Go R5 system (GTIN 00195278450319 / GTIN 00195278451774); System ID: VENGO000382 VGB002128 VGB003021 VGD000325 VGD002313 VGD000452 VGD000488 VGD002390 VGC006411 VGB002040 VGD000354 VGC000685 VGD001444 VGC006698 VGC007776 RVGC000034 RVGC000035 VGD002256 VGD002533 VGD002535 VGD002536 VGB001162 VGC007292 VGC007119 VGC006083 VGC006841 VGB001011 VGC000147 VGD001510 RVGC000559 RVGC000562 VGD000044 VGD001371 VGD001372 VGD001375 VGD001374 VGD001373 VGD001625 VGD001638 VGC000526 RVGD002184 VGD002513 VGB002239 VGD001705 VGD002307 VGC000746 VGC004373 VGC004378 VGC006707 RVGC007218 RVGC000591 VGD001899 RVGC004147 VGC004351 VGC007098 VGC007102 VGC007105 RVGC000024 RVGC004165 RVGD001551 RVGB000480 RVGB002675 VGC007113 VGD000091 RVGD001076 RVGB000467 VENGO000545 VGC007350 VGD001731 VGB002526 VGC000227 VGD001964 VGD002225 RVGC000303 RVGB000757 RVGB000797 RVGC000302 RVGC000554 VGC000799 RVGC006372 RVGC006771 VGC007879 VGC007880 VGD000524 RVGB000791 VGD001873 VGD002221 VGD002227 VGD002467 VGD000730 VGD001872 VGC007607 VGC007611 RVGC007204 VGC006763 VGD000731 VGD000843 RVGB000694 VGD000553 VGD000554 VGD000558 VGD001336 VGC000898 VGD000200 VGC006715 VGD002460 VGD002462 VGD002427 RVGB000032 RVGC000594 RVGC000617 VGD001738 VGD001747 RVGC006758 RVGD001055 VGB000796 VGB000901 RVGD001795 VGD001400 VGD001401 VGB002539 VGB002613 VGB001125 VGD001200 VGD001257 VGD001258 VGD001258 VGD001257 VGD001261 VGD001257 VGC000386 RVGD001071 VGD002275 VGD001701 VGD001704 VENGO000317 VGB002122 VGD001687 VGD001884 VGD0…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide - US Nationwide distribution.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-1555-2025: GE Medical Systems, LLC is recalling Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG, H45135VGW), R3 Surgery for China (Model Number H45113VGSU), R3 PeriOP for China (Model Number H45113VGPO), R3 Expert for China (Model Number H45113VGEX ), R3 Pro for China (Model Number H45113VGPR), R3 Performance for China, R3 Intervention for China, R3 Surgery for China (Model Number H45113VGSU) diagnostic ultrasound systems
text: The FDA logged enforcement record Z-1555-2025: GE Medical Systems, LLC is voluntarily recalling Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG, H45135VGW), R3 Surgery for China (Model Number H45113VGSU), R3 PeriOP for China (Model Number H45113VGPO), R3 Expert for China (Model Number H45113VGEX ), R3 Pro for China (Model Number H45113VGPR), R3 Performance for China, R3 Intervention for China, R3 Surgery for China (Model Number H45113VGSU) diagnostic ultrasound systems — reason: The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-03-06. Affected lots/codes: UDI-DI: Venue Go R2 system (GTIN 00840682138840); Venue Go R3 system (GTIN 00840682190503 / GTIN 00195278358011); Venue Go R4 system (GTIN 00195278516510 / GTIN 00195278516527); Venue Go R3 Surgery for China (GTIN 00195278547866) Venue Go R3 PeriOP for China (GTIN 00195278548344) Venue Go R3 Expert for China (GTIN 00195278547262) Venue Go R3 Pro for China (GTIN 00195278547828) Venue Go R3 Performance for China (GTIN 00195278547842) Venue Go R3 Intervention for China (GTIN 00195278548061) Venue Go R5 system (GTIN 00195278450319 / GTIN 00195278451774); System ID: VENGO000382 VGB002128 VGB003021 VGD000325 VGD002313 VGD000452 VGD000488 VGD002390 VGC006411 VGB002040 VGD000354 VGC000685 VGD001444 VGC006698 VGC007776 RVGC000034 RVGC000035 VGD002256 VGD002533 VGD002535 VGD002536 VGB001162 VGC007292 VGC007119 VGC006083 VGC006841 VGB001011 VGC000147 VGD001510 RVGC000559 RVGC000562 VGD000044 VGD001371 VGD001372 VGD001375 VGD001374 VGD001373 VGD001625 VGD001638 VGC000526 RVGD002184 VGD002513 VGB002239 VGD001705 VGD002307 VGC000746 VGC004373 VGC004378 VGC006707 RVGC007218 RVGC000591 VGD001899 RVGC004147 VGC004351 VGC007098 VGC007102 VGC007105 RVGC000024 RVGC004165 RVGD001551 RVGB000480 RVGB002675 VGC0071…
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-1555-2025 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.