X8-2t Transducer Probe
type: Dataset
description: FDA recall Z-2413-2025 — Philips Ultrasound, Inc is recalling X8-2t 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: X8-2t Transducer Probe
  type: MedicalDevice
  manufacturer: Philips Ultrasound, Inc
claims: FDA recall Z-2413-2025: Philips Ultrasound, Inc is recalling X8-2t Transducer Probe
claims: FDA classified recall Z-2413-2025 as Class III
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2413-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2413-2025
      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. 989605455171, 989605400802, 989605409562, 989605414122; UDI: (01)00884838069718(21)B2DKRP, (01)00884838069718(21)B2XD88, (01)00884838069718(21)B3DRBX, (01)00884838069718(21)B3DRF0, (01)00884838069718(21)B3DRGX, (01)00884838069718(21)F0GWCW, (01)00884838069718(21)B277WX, (01)00884838069718(21)F04WX2, (01)00884838069718(21)F0B4PV, (01)00884838069718(21)B2VQJ5, (01)00884838069718(21)F010V3, (01)00884838069718(21)F042C2, (01)00884838069718(21)F06TQ3, (01)00884838069718(21)F086C1, (01)00884838069718(21)F086C2, (01)00884838069718(21)F08835, (01)00884838069718(21)F09BV3, (01)00884838069718(21)F0DK0W, (01)00884838069718(21)F0FDNF, (01)00884838069718(21)F0K1TQ, (01)00884838069718(21)F0K5JZ, (01)00884838069718(21)F0186H, (01)00884838069718(21)F03RVN, (01)00884838069718(21)F052P3, (01)00884838069718(21)F05445, (01)00884838069718(21)F0BRLQ, (01)00884838069718(21)F0D1XZ, (01)00884838069718(21)B2JHG3, (01)00884838069718(21)B39B92, (01)00884838069718(21)F0LW0Y, (01)00884838069718(21)F0LW10, (01)00884838069718(21)F02ZG0, (01)00884838069718(21)B3DRL7, (01)00884838069718(21)F016MN, (01)00884838069718(21)F02R78, (01)00884838069718(21)F04C9H, (01)00884838069718(21)F04ZB0, (01)00884838069718(21)F0640W, (01)00884838069718(21)F09JV7, (01)00884838069718(21)F0CPG5, (01)00884838069718(21)F0CY3N, (01)00884838069718(21)F0DT5W, (01)00884838069718(21)F0F1QM, (01)00884838069718(21)F0FLG7, (01)00884838069718(21)F0FRL7, (01)00884838069718(21)F0GMVF, (01)00884838069718(21)F0GR8T, (01)00884838069718(21)F0GRGV, (01)00884838069718(21)F0GTBQ, (01)00884838069718(21)F0GTC0, (01)00884838069718(21)F0GVL6, (01)00884838069718(21)F0GWYQ, (01)00884838069718(21)F0GZBN, (01)00884838069718(21)F0LHWM, (01)00884838069718(21)B2VQBH, (01)00884838069718(21)F055VW, (01)00884838069718(21)F0BJ8J, (01)00884838069718(21)F0D02W, 010088483806971821F0GHKX, (01)00884838069718(21)F02MYD, (01)00884838069718(21)F02GFC, (01)00884838069718(21)F04XZ4, (01)00884838069718(21)F0F1Q1, (01)00884838069718(21)F0F4DL, (01)008848380…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide distribution.
      status: recorded

FDA recall Z-2413-2025: Philips Ultrasound, Inc is recalling X8-2t Transducer Probe
type: Claim
text: The FDA logged enforcement record Z-2413-2025: Philips Ultrasound, Inc is voluntarily recalling X8-2t 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. 989605455171, 989605400802, 989605409562, 989605414122; UDI: (01)00884838069718(21)B2DKRP, (01)00884838069718(21)B2XD88, (01)00884838069718(21)B3DRBX, (01)00884838069718(21)B3DRF0, (01)00884838069718(21)B3DRGX, (01)00884838069718(21)F0GWCW, (01)00884838069718(21)B277WX, (01)00884838069718(21)F04WX2, (01)00884838069718(21)F0B4PV, (01)00884838069718(21)B2VQJ5, (01)00884838069718(21)F010V3, (01)00884838069718(21)F042C2, (01)00884838069718(21)F06TQ3, (01)00884838069718(21)F086C1, (01)00884838069718(21)F086C2, (01)00884838069718(21)F08835, (01)00884838069718(21)F09BV3, (01)00884838069718(21)F0DK0W, (01)00884838069718(21)F0FDNF, (01)00884838069718(21)F0K1TQ, (01)00884838069718(21)F0K5JZ, (01)00884838069718(21)F0186H, (01)00884838069718(21)F03RVN, (01)00884838069718(21)F052P3, (01)00884838069718(21)F05445, (01)00884838069718(21)F0BRLQ, (01)00884838069718(21)F0D1XZ, (01)00884838069718(21)B2JHG3, (01)00884838069718(21)B39B92, (01)00884838069718(21)F0LW0Y, (01)00884838069718(21)F0LW10, (01)00884838069718(21)F02ZG0, (01)00884838069718(21)B3DRL7, (01)00884838069718(21)F016MN, (01)00884838069718(21)F02R78, (01)00884838069718(21)F04C9H, (01)00884838069718(21)F04ZB0, (01)00884838069718(21)F0640W, (01)00884838069718(21)F09JV7, (01)00884838069718(21)F0CPG5, (01)00884838069718(21)F0CY3N, (01)00884838069718(21)F0DT5W, (01)00884838069718(21)F0F1QM, (01)00884838069718(21)F0FLG7, (01)00884838069718(21)F0FRL7, (01)00884838069718(21)F0GMVF, (01)00884838069718(21)F0GR8T, (01)00884838069718(21)F0GRGV, (01)00884838069718(21)F0GTBQ, (01)00884838069718(21)F0GTC0, (01)00884838069718(21)F0GVL6, (01)00884838069718(21)F0GWYQ, (01)00884838069718(21)F0GZBN, (01…
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-2413-2025 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.