Z-1556-2025.jsonld
type: Dataset
name: Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system (Model Numbers H45335VFS, H45335VFSW), R3 Surgery for China, R3 PeriOP for China, R3 Expert for China, R3 Pro for China, R3 Performance for China, R3 Intervention for China diagnostic ultrasound systems
description: FDA recall Z-1556-2025 — GE Medical Systems, LLC is recalling Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system (Model Numbers H45335VFS, H45335VFSW), R3 Surgery for China, R3 PeriOP for China, R3 Expert for China, R3 Pro for China, R3 Performance for China, R3 Intervention for China 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 Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system (Model Numbers H45335VFS, H45335VFSW), R3 Surgery for China, R3 PeriOP for China, R3 Expert for China, R3 Pro for China, R3 Performance for China, R3 Intervention for China diagnostic ultrasound systems
  manufacturer: GE Medical Systems, LLC
claims: enforcement-record
claims: FDA classified recall Z-1556-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1556-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1556-2025
      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 Fit R3 system (GTIN 00195278194275 / GTIN 00195278361400); Venue Fit R4 system (GTIN 00195278516497 / GTIN 00195278516503); Venue Fit R3 Surgery for China (GTIN 00195278552488); Venue Fit R3 PeriOP for China (GTIN 00195278552501); Venue Fit R3 Expert for China (GTIN 00195278552402); Venue Fit R3 Pro for China (GTIN 00195278552419); Venue Fit R3 Performance for China (GTIN 00195278552440); Venue Fit R3 Intervention for China (GTIN 00195278552495); Venue Fit R5 system (GTIN 00195278424938 / GTIN 00195278425041); Serial IDs: VFC001530 VFD000259 RVFD000123 RVFD000429 VFD001037 RVFD000030 RVFD000035 RVFD000523 VFC000864 VFC000873 VFC000877 VFC000881 VFC000364 VFC000638 VFC000640 VFC000490 RVFC000952 RVFD000297 VFD000567LO VFD000632 VFC000297 VFC000865 VFC000871 RVFD000061 RVFD000432 VFC000665 VFC001417 RVFD000036 VFC001289 RVFD000059 VFC000435 VFC000644 VFD000633 VFC001324 VFD000797 VFC001277 VFD000665 VFD000668 VFC000819 VFC000506 VFC000507 VFC000516 VFD000578 RVFD000122 VFC001254 RVFC000164 VFD000295 VFC001205 VFC000470 VFD000522 VFC000111 VFD000334 VFD001053 VFC000614 RVFD000071 RVFD000072 VFD000073 VFC000942 RVFD000947 VFD000985 VFD000534 VFC000527 VFC000251 VFC001225 VFD000250 VFC001535 VFC001535 VFD000883 VFC001323 VFD000781 VFD001081 RVFD000019 VFC001370 VFC001371 RVFD000067 RVFC001427 VFD000184 VFC000349 VFC001538 VFC001542 VFC001519 VFC000981 VFC000985 VFC000511 VFC000515 VFC001647 VFC001143 VFD000150 VFD000614 VFD000646 VFD000647 VFD000622 VFC000351 VFC000332 RVFD000933 VFC000641 VFC000551 VFD000514 RVFC000166 VFC000993 VFD000205 VFD000579 VFD000580 VFD000585 VFD000586 VFD000546 RVFC000169 VFC000312 VFD000208 VFC000360 VFD000210 VFD000163 VFD000011 VFD000039 VFD000040 VFD000041 VFD000042 VFD000044 VFD000045 VFD000046 VFD000047 VFD000048 VFD000049 VFD000050 VFD000052 VFD000879 VFC000368 VFC000899 VFD000710 VFC001263 RVFD000688 VFC000667 VFC000669 VFD000849 VFD000850 VFC001229 VFD000214 VFD000962 VFC000786 VFC000493 VFC000497 VFC000497 VFC000497 VFC…
      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-1556-2025: GE Medical Systems, LLC is recalling Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system (Model Numbers H45335VFS, H45335VFSW), R3 Surgery for China, R3 PeriOP for China, R3 Expert for China, R3 Pro for China, R3 Performance for China, R3 Intervention for China diagnostic ultrasound systems
text: The FDA logged enforcement record Z-1556-2025: GE Medical Systems, LLC is voluntarily recalling Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system (Model Numbers H45335VFS, H45335VFSW), R3 Surgery for China, R3 PeriOP for China, R3 Expert for China, R3 Pro for China, R3 Performance for China, R3 Intervention for China 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 Fit R3 system (GTIN 00195278194275 / GTIN 00195278361400); Venue Fit R4 system (GTIN 00195278516497 / GTIN 00195278516503); Venue Fit R3 Surgery for China (GTIN 00195278552488); Venue Fit R3 PeriOP for China (GTIN 00195278552501); Venue Fit R3 Expert for China (GTIN 00195278552402); Venue Fit R3 Pro for China (GTIN 00195278552419); Venue Fit R3 Performance for China (GTIN 00195278552440); Venue Fit R3 Intervention for China (GTIN 00195278552495); Venue Fit R5 system (GTIN 00195278424938 / GTIN 00195278425041); Serial IDs: VFC001530 VFD000259 RVFD000123 RVFD000429 VFD001037 RVFD000030 RVFD000035 RVFD000523 VFC000864 VFC000873 VFC000877 VFC000881 VFC000364 VFC000638 VFC000640 VFC000490 RVFC000952 RVFD000297 VFD000567LO VFD000632 VFC000297 VFC000865 VFC000871 RVFD000061 RVFD000432 VFC000665 VFC001417 RVFD000036 VFC001289 RVFD000059 VFC000435 VFC000644 VFD000633 VFC001324 VFD000797 VFC001277 VFD000665 VFD000668 VFC000819 VFC000506 VFC000507 VFC000516 VFD000578 RVFD000122 VFC001254 RVFC000164 VFD000295 VFC001205 VFC000470 VFD000522 VFC000111 VFD000334 VFD001053 VFC000614 RVFD000071 RVFD000072 VFD000073 VFC000942 RVFD000947 VFD000985 VFD000534 VFC000527 VFC000251 VFC001225 VFD000250 VFC001535 VFC001535 VFD000883 VFC001323 VFD000781 VFD001081 RVFD000019 VFC001370 VFC001371 RVFD000067 RVFC001427 VFD000184 VFC000349 V…
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-1556-2025 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.