L18-5 Transducer Probe
type: Dataset
description: FDA recall Z-2380-2025 — Philips Ultrasound, Inc is recalling L18-5 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: L18-5 Transducer Probe
  type: MedicalDevice
  manufacturer: Philips Ultrasound, Inc
claims: FDA recall Z-2380-2025: Philips Ultrasound, Inc is recalling L18-5 Transducer Probe
claims: FDA classified recall Z-2380-2025 as Class III
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2380-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2380-2025
      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. 989605409582, 989605438531; UDI: (01)00884838061590(21)B211XD, (01)00884838061590(21)B29X8C, (01)00884838061590(21)B2VJ24, (01)00884838061590(21)F010Y2, (01)00884838061590(21)F04JYB, (01)00884838061590(21)F06LTM, 010088483806159021F024QP, (01)00884838061590(21)B23T88, (01)00884838061590(21)B2KLW4, (01)00884838061590(21)B2LL93, (01)00884838061590(21)F0DJP0, (01)00884838061590(21)B1ZQTL, (01)00884838061590(21)B2ZCHP, (01)00884838061590(21)B1NXX9, (01)00884838061590(21)B1QBQ0, (01)00884838061590(21)F01CK2, (01)00884838061590(21)B2T427, (01)00884838061590(21)B2X16F, (01)00884838061590(21)F08GP4, (01)00884838061590(21)B1RYJ0, (01)00884838061590(21)B26Q0R, (01)00884838061590(21)B285X3, (01)00884838061590(21)B2860F, (01)00884838061590(21)B286JG, (01)00884838061590(21)B28C28, (01)00884838061590(21)B28MPM, (01)00884838061590(21)B28641, (01)00884838061590(21)F09LKN, (01)00884838061590(21)B1P4DQ, (01)00884838061590(21)B2XFLV, (01)00884838061590(21)F0C64G, (01)00884838061590(21)B1ML3D, (01)00884838061590(21)B1NVNV, (01)00884838061590(21)B3FC9C, (01)00884838061590(21)B3H0RH, (01)00884838061590(21)B3VBR3, (01)00884838061590(21)F00YXV, (01)00884838061590(21)F03DK8, (01)00884838061590(21)F04DBC, (01)00884838061590(21)F04ZZ8, (01)00884838061590(21)F0604G, (01)00884838061590(21)F07YR8, (01)00884838061590(21)F08WT0, (01)00884838061590(21)F098T9, (01)00884838061590(21)F09FJZ, (01)00884838061590(21)F09YZ7, (01)00884838061590(21)F0C6GT, (01)00884838061590(21)F0C6WQ, (01)00884838061590(21)F0C7N6, (01)00884838061590(21)F0CPHL, (01)00884838061590(21)F0FFDB, (01)00884838061590(21)F0G21M, (01)00884838061590(21)F0GB84, (01)00884838061590(21)F0H75R, (01)00884838061590(21)F0H8LN, (01)00884838061590(21)F0HC3Z, (01)00884838061590(21)F0HMQ8, (01)00884838061590(21)F0HMQF, (01)00884838061590(21)F0HPP0, (01)00884838061590(21)F0HW93, (01)00884838061590(21)F0K5GT, (01)00884838061590(21)F0K5H0, (01)00884838061590(21)F0K7YX, (01)00884838061590(21)F0KKB3, (01)00884838061590(21)B1NVTK, (01)0088483…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide distribution.
      status: recorded

FDA recall Z-2380-2025: Philips Ultrasound, Inc is recalling L18-5 Transducer Probe
type: Claim
text: The FDA logged enforcement record Z-2380-2025: Philips Ultrasound, Inc is voluntarily recalling L18-5 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. 989605409582, 989605438531; UDI: (01)00884838061590(21)B211XD, (01)00884838061590(21)B29X8C, (01)00884838061590(21)B2VJ24, (01)00884838061590(21)F010Y2, (01)00884838061590(21)F04JYB, (01)00884838061590(21)F06LTM, 010088483806159021F024QP, (01)00884838061590(21)B23T88, (01)00884838061590(21)B2KLW4, (01)00884838061590(21)B2LL93, (01)00884838061590(21)F0DJP0, (01)00884838061590(21)B1ZQTL, (01)00884838061590(21)B2ZCHP, (01)00884838061590(21)B1NXX9, (01)00884838061590(21)B1QBQ0, (01)00884838061590(21)F01CK2, (01)00884838061590(21)B2T427, (01)00884838061590(21)B2X16F, (01)00884838061590(21)F08GP4, (01)00884838061590(21)B1RYJ0, (01)00884838061590(21)B26Q0R, (01)00884838061590(21)B285X3, (01)00884838061590(21)B2860F, (01)00884838061590(21)B286JG, (01)00884838061590(21)B28C28, (01)00884838061590(21)B28MPM, (01)00884838061590(21)B28641, (01)00884838061590(21)F09LKN, (01)00884838061590(21)B1P4DQ, (01)00884838061590(21)B2XFLV, (01)00884838061590(21)F0C64G, (01)00884838061590(21)B1ML3D, (01)00884838061590(21)B1NVNV, (01)00884838061590(21)B3FC9C, (01)00884838061590(21)B3H0RH, (01)00884838061590(21)B3VBR3, (01)00884838061590(21)F00YXV, (01)00884838061590(21)F03DK8, (01)00884838061590(21)F04DBC, (01)00884838061590(21)F04ZZ8, (01)00884838061590(21)F0604G, (01)00884838061590(21)F07YR8, (01)00884838061590(21)F08WT0, (01)00884838061590(21)F098T9, (01)00884838061590(21)F09FJZ, (01)00884838061590(21)F09YZ7, (01)00884838061590(21)F0C6GT, (01)00884838061590(21)F0C6WQ, (01)00884838061590(21)F0C7N6, (01)00884838061590(21)F0CPHL, (01)00884838061590(21)F0FFDB, (01)00884838061590(21)F0G21M, (01)00884838061590(21)F0GB84, (01)00884838061590(21)F0H75R, (01)0…
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-2380-2025 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.