S4-2 Transducer Probe
type: Dataset
description: FDA recall Z-2393-2025 — Philips Ultrasound, Inc is recalling S4-2 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: S4-2 Transducer Probe
  type: MedicalDevice
  manufacturer: Philips Ultrasound, Inc
claims: FDA recall Z-2393-2025: Philips Ultrasound, Inc is recalling S4-2 Transducer Probe
claims: FDA classified recall Z-2393-2025 as Class III
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2393-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2393-2025
      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. 989605414692, 989605463421, 989605442131, 989605387731, 989605412042, 989605430222, 989605381211, 989605430652, 989605361982, 989605463421; UDI: (01)00884838067844(21)B2TH04, (01)00884838067844(21)B2TH20, (01)00884838067844(21)B2TH5R, (01)00884838067844(21)B2TH94, (01)00884838067844(21)B2TH95, (01)00884838067844(21)B2TRZG, (01)04719873000067(21)F0771Y, (01)04719873000067(21)F0K891, 010471987300006721B24RHN, (01)00884838067844(21)B2ZLWP, (01)00884838067844(21)B1N04C, (01)00884838067844(21)B1N0D2, (01)00884838067844(21)B2PXTV, (01)00884838067844(21)B2PY5Z, (01)00884838067844(21)B2TRRF, (01)00884838067844(21)B1RDM4, (01)04719873000067(21)B3TLRJ, (01)04719873000067(21)B3VZCQ, (01)00884838067844(21)B35KQ5, (01)00884838067844(21)B2ZLK8, (01)00884838067844(21)B2ZTKD, (01)00884838067844(21)B1JVZF, (01)00884838067844(21)F0G5KZ, (01)00884838067844(21)B20GTL, (01)00884838067844(21)B20QB6, 010088483806784421F0B41N, 010088483806784421F0B41W, (01)00884838067844(21)B2PTGM, (01)00884838067844(21)B2TGKT, (01)00884838067844(21)B2TGL2, (01)00884838067844(21)B2TH12, (01)00884838067844(21)B1RF7C, (01)00884838067844(21)B2ZTKF, (01)00884838067844(21)B3W869, (01)00884838067844(21)B3TJP3, (01)00884838067844(21)B3TJWM, 010088483806784421B3Y0V9, (01)00884838067844(21)B2DC5Z, (01)00884838067844(21)B2PN5J, (01)00884838067844(21)F0HWVH, (01)00884838067844(21)F0HYM4, (01)00884838067844(21)F0J4F6, (01)00884838067844(21)F0LH1L, (01)00884838067844(21)B1WVHX, (01)00884838067844(21)B27QW7, (01)00884838067844(21)B27R75, (01)00884838067844(21)B2DCF6, (01)00884838067844(21)B2DCR0, (01)00884838067844(21)B2DCR2, (01)00884838067844(21)B2DDWW, (01)00884838067844(21)B2DDZF, (01)00884838067844(21)B2DF8P, (01)00884838067844(21)B2DF9F, (01)00884838067844(21)B2DFB1, (01)00884838067844(21)B2DFQ4, (01)00884838067844(21)B40XRP, (01)00884838067844(21)B2DCJ2, (01)00884838067844(21)B2H8T7, (01)00884838067844(21)B2H91C, (01)00884838067844(21)F07V8Y, (01)00884838067844(21)B1MVGT, (01)00884838067844(21)B1MWLY, (…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide distribution.
      status: recorded

FDA recall Z-2393-2025: Philips Ultrasound, Inc is recalling S4-2 Transducer Probe
type: Claim
text: The FDA logged enforcement record Z-2393-2025: Philips Ultrasound, Inc is voluntarily recalling S4-2 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. 989605414692, 989605463421, 989605442131, 989605387731, 989605412042, 989605430222, 989605381211, 989605430652, 989605361982, 989605463421; UDI: (01)00884838067844(21)B2TH04, (01)00884838067844(21)B2TH20, (01)00884838067844(21)B2TH5R, (01)00884838067844(21)B2TH94, (01)00884838067844(21)B2TH95, (01)00884838067844(21)B2TRZG, (01)04719873000067(21)F0771Y, (01)04719873000067(21)F0K891, 010471987300006721B24RHN, (01)00884838067844(21)B2ZLWP, (01)00884838067844(21)B1N04C, (01)00884838067844(21)B1N0D2, (01)00884838067844(21)B2PXTV, (01)00884838067844(21)B2PY5Z, (01)00884838067844(21)B2TRRF, (01)00884838067844(21)B1RDM4, (01)04719873000067(21)B3TLRJ, (01)04719873000067(21)B3VZCQ, (01)00884838067844(21)B35KQ5, (01)00884838067844(21)B2ZLK8, (01)00884838067844(21)B2ZTKD, (01)00884838067844(21)B1JVZF, (01)00884838067844(21)F0G5KZ, (01)00884838067844(21)B20GTL, (01)00884838067844(21)B20QB6, 010088483806784421F0B41N, 010088483806784421F0B41W, (01)00884838067844(21)B2PTGM, (01)00884838067844(21)B2TGKT, (01)00884838067844(21)B2TGL2, (01)00884838067844(21)B2TH12, (01)00884838067844(21)B1RF7C, (01)00884838067844(21)B2ZTKF, (01)00884838067844(21)B3W869, (01)00884838067844(21)B3TJP3, (01)00884838067844(21)B3TJWM, 010088483806784421B3Y0V9, (01)00884838067844(21)B2DC5Z, (01)00884838067844(21)B2PN5J, (01)00884838067844(21)F0HWVH, (01)00884838067844(21)F0HYM4, (01)00884838067844(21)F0J4F6, (01)00884838067844(21)F0LH1L, (01)00884838067844(21)B1WVHX, (01)00884838067844(21)B27QW7, (01)00884838067844(21)B27R75, (01)00884838067844(21)B2DCF6, (01)00884838067844(21)B2DCR0, (01)00884838067844(21)B2DCR2, (01)00884838067844(21)B2DDWW, (01)00884838067844(21)B2DD…
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-2393-2025 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.