C9-4v Transducer Probe
type: Dataset
description: FDA recall Z-2364-2025 — Philips Ultrasound, Inc is recalling C9-4v Transducer Probe (Devices, Class III). 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: C9-4v Transducer Probe
  type: MedicalDevice
  manufacturer: Philips Ultrasound, Inc
claims: FDA recall Z-2364-2025: Philips Ultrasound, Inc is recalling C9-4v Transducer Probe
claims: FDA classified recall Z-2364-2025 as Class III
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2364-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2364-2025
      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 III
      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: Philips Ultrasound, Inc
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2025-07-03
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: Model No. 989605389252, 989605418972, 989605463411, 989605442141, 989605463411, 989605389251, 989605412042, 989605387091, 989605418971; UDI: (01)00884838061392(21)B1Q4CD, (01)00884838061392(21)B1YXKM, (01)00884838061392(21)B323T7, (01)00884838061392(21)F00QWD, (01)00884838061392(21)F029RH, (01)00884838067875(21)B1N3PG, (01)00884838067875(21)B1N3PZ, (01)00884838067875(21)B1N3TV, (01)00884838067875(21)B1N3W3, (01)00884838067875(21)B1N3ZJ, (01)00884838067875(21)B20M3Y, (01)00884838067875(21)B27LZD, (01)00884838067875(21)B27LZH, (01)00884838067875(21)B2TR7C, (01)00884838067875(21)B2ZMR5, (01)00884838067875(21)B32NH8, (01)00884838067875(21)B39VT0, (01)00884838067875(21)B410QW, (01)00884838067875(21)F05HKB, (01)00884838067875(21)F0JQQG, (01)04719873000050(21)B2PTCD, (01)04719873000050(21)B32PHY, 010088483806787521B3XMR5, N/A, N/A, N/A, N/A, N/A, N/A, N/A, (01)00884838067875(21)F0L3Z8, (01)00884838061392(21)B30WYR, (01)00884838067875(21)B3Z7ZM, (01)00884838061392(21)B232FN, (01)00884838061392(21)B25HKF, (01)00884838061392(21)B3LLMF, (01)00884838061392(21)B1WF1V, (01)00884838061392(21)B25JBQ, (01)00884838061392(21)B26BTD, (01)00884838061392(21)F07X9C, (01)00884838061392(21)F089ZV, (01)00884838067875(21)B1WZDW, (01)00884838067875(21)F08RGM, (01)00884838061392(21)B1ZV0G, (01)00884838061392(21)B1ZV0K, (01)00884838061392(21)B1ZV0M, (01)00884838061392(21)B1ZV2W, (01)00884838061392(21)B20233, (01)00884838061392(21)B2LTD7, (01)00884838061392(21)B2LTMJ, (01)00884838061392(21)B2LTP6, (01)00884838061392(21)F00H2X, N/A, (01)00884838067875(21)F0JDY9, (01)00884838067875(21)B20N4V, (01)04719873000050(21)F09LQ3, (01)00884838061392(21)B330ZF, (01)00884838067875(21)B27KHV, (01)00884838067875(21)B27KLR, (01)00884838067875(21)F057KN, (01)00884838067875(21)F057N0, (01)00884838067875(21)B1WZ87, (01)00884838067875(21)B1WZN2, (01)00884838067875(21)B20D67, (01)00884838067875(21)B20N6T, N/A, (01)00884838067875(21)B20CG5, (01)00884838061392(21)B1YX7R, (01)00884838067875(21)F0HNZF, (01)00884838067875…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide distribution.
      status: recorded

FDA recall Z-2364-2025: Philips Ultrasound, Inc is recalling C9-4v Transducer Probe
type: Claim
text: The FDA logged enforcement record Z-2364-2025: Philips Ultrasound, Inc is voluntarily recalling C9-4v Transducer Probe — reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-07-03. Affected lots/codes: Model No. 989605389252, 989605418972, 989605463411, 989605442141, 989605463411, 989605389251, 989605412042, 989605387091, 989605418971; UDI: (01)00884838061392(21)B1Q4CD, (01)00884838061392(21)B1YXKM, (01)00884838061392(21)B323T7, (01)00884838061392(21)F00QWD, (01)00884838061392(21)F029RH, (01)00884838067875(21)B1N3PG, (01)00884838067875(21)B1N3PZ, (01)00884838067875(21)B1N3TV, (01)00884838067875(21)B1N3W3, (01)00884838067875(21)B1N3ZJ, (01)00884838067875(21)B20M3Y, (01)00884838067875(21)B27LZD, (01)00884838067875(21)B27LZH, (01)00884838067875(21)B2TR7C, (01)00884838067875(21)B2ZMR5, (01)00884838067875(21)B32NH8, (01)00884838067875(21)B39VT0, (01)00884838067875(21)B410QW, (01)00884838067875(21)F05HKB, (01)00884838067875(21)F0JQQG, (01)04719873000050(21)B2PTCD, (01)04719873000050(21)B32PHY, 010088483806787521B3XMR5, N/A, N/A, N/A, N/A, N/A, N/A, N/A, (01)00884838067875(21)F0L3Z8, (01)00884838061392(21)B30WYR, (01)00884838067875(21)B3Z7ZM, (01)00884838061392(21)B232FN, (01)00884838061392(21)B25HKF, (01)00884838061392(21)B3LLMF, (01)00884838061392(21)B1WF1V, (01)00884838061392(21)B25JBQ, (01)00884838061392(21)B26BTD, (01)00884838061392(21)F07X9C, (01)00884838061392(21)F089ZV, (01)00884838067875(21)B1WZDW, (01)00884838067875(21)F08RGM, (01)00884838061392(21)B1ZV0G, (01)00884838061392(21)B1ZV0K, (01)00884838061392(21)B1ZV0M, (01)00884838061392(21)B1ZV2W, (01)00884838061392(21)B20233, (01)00884838061392(21)B2LTD7, (01)00884838061392(21)B2LTMJ, (01)00884838061392(21)B2LTP6, (01)00884838061392(21)F00H2X, N/A, (01)00884838067875(21)F0JDY9, (01)00884838067875(21)B20N4V, (01)04719873000050(21)F09LQ3, (01)00884838061392(21)B330ZF, (01)0088483806787…
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-2364-2025 as Class III
type: Claim
text: The FDA assigned this recall Class III: Class III — the FDA judged the product is unlikely to cause 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 III
  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.