L12-4 Transducer Probe
type: Dataset
description: FDA recall Z-2373-2025 — Philips Ultrasound, Inc is recalling L12-4 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: L12-4 Transducer Probe
  type: MedicalDevice
  manufacturer: Philips Ultrasound, Inc
claims: FDA recall Z-2373-2025: Philips Ultrasound, Inc is recalling L12-4 Transducer Probe
claims: FDA classified recall Z-2373-2025 as Class III
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2373-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2373-2025
      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. 989605430652, 989605409562, 989605427122, 989605463401, 989605430651, 989605442161, 989605418963, 989605387852, 989605418701, 989605387081, 989605412042, 989605451171, 989605463401; UDI: (01)00884838061484(21)B1X9ZR, (01)00884838061484(21)B2Y9KT, (01)00884838061484(21)B30VBJ, (01)00884838061484(21)F001VD, (01)00884838061583(21)B1XBZR, (01)00884838061644(21)B1NM93, (01)00884838061644(21)B1NM97, (01)00884838061644(21)B1PKN3, (01)00884838061644(21)B1PKNX, (01)00884838061644(21)B1QC9Q, (01)00884838061644(21)B2C3WV, (01)00884838061644(21)B36X3B, (01)00884838061644(21)B3G91R, (01)04719873000043(21)B3Q2BY, (01)04719873000043(21)F0FFRZ, (01)04719873000043(21)F0HHBM, (01)04719873000043(21)F0JKV3, 010471987300004321B24KV9, (01)00884838067882(21)B32NGP, (01)00884838067882(21)B3FP9D, (01)00884838067882(21)B27L19, (01)00884838067882(21)B2D56Y, (01)00884838061491(21)B2JT8X, (01)00884838067882(21)B1N3XG, (01)00884838067882(21)B1N3Z3, (01)00884838067882(21)B2PT8J, (01)00884838067882(21)B2THVB, (01)00884838067882(21)B2THVK, (01)00884838067882(21)B2ZN60, (01)00884838067882(21)F0DYMD, (01)00884838067882(21)F0DYMR, 010088483806788221F0G3JP, 010088483806788221F0G869, 010088483806788221F0G86F, 010088483806788221F0GCX4, (01)00884838061644(21)B25L78, (01)00884838061644(21)B25L7X, (01)00884838067882(21)B3XP02, (01)00884838061644(21)B1WDL1, (01)00884838067882(21)F083L7, (01)00884838067882(21)F0JDWK, (01)00884838061484(21)B28GVF, (01)00884838061484(21)F071WF, (01)04719873000043(21)B3L8J2, (01)04719873000043(21)B3W6FY, (01)04719873000043(21)F08BWB, (01)00884838067882(21)B32P1T, (01)00884838067882(21)B1RGL4, (01)00884838067882(21)B1RNKM, (01)00884838067882(21)B3WWCK, (01)00884838061644(21)B1XBK8, (01)00884838067882(21)B2TQT9, (01)00884838061644(21)B1Z5B5, (01)00884838067882(21)B3W67P, (01)00884838067882(21)B20CXM, (01)00884838067882(21)B20MM3, (01)00884838067882(21)B3FN0X, (01)00884838067882(21)B2TQRY, (01)00884838067882(21)B2TQVM, (01)00884838067882(21)B35M34, (01)00884838067882(21)F…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide distribution.
      status: recorded

FDA recall Z-2373-2025: Philips Ultrasound, Inc is recalling L12-4 Transducer Probe
type: Claim
text: The FDA logged enforcement record Z-2373-2025: Philips Ultrasound, Inc is voluntarily recalling L12-4 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. 989605430652, 989605409562, 989605427122, 989605463401, 989605430651, 989605442161, 989605418963, 989605387852, 989605418701, 989605387081, 989605412042, 989605451171, 989605463401; UDI: (01)00884838061484(21)B1X9ZR, (01)00884838061484(21)B2Y9KT, (01)00884838061484(21)B30VBJ, (01)00884838061484(21)F001VD, (01)00884838061583(21)B1XBZR, (01)00884838061644(21)B1NM93, (01)00884838061644(21)B1NM97, (01)00884838061644(21)B1PKN3, (01)00884838061644(21)B1PKNX, (01)00884838061644(21)B1QC9Q, (01)00884838061644(21)B2C3WV, (01)00884838061644(21)B36X3B, (01)00884838061644(21)B3G91R, (01)04719873000043(21)B3Q2BY, (01)04719873000043(21)F0FFRZ, (01)04719873000043(21)F0HHBM, (01)04719873000043(21)F0JKV3, 010471987300004321B24KV9, (01)00884838067882(21)B32NGP, (01)00884838067882(21)B3FP9D, (01)00884838067882(21)B27L19, (01)00884838067882(21)B2D56Y, (01)00884838061491(21)B2JT8X, (01)00884838067882(21)B1N3XG, (01)00884838067882(21)B1N3Z3, (01)00884838067882(21)B2PT8J, (01)00884838067882(21)B2THVB, (01)00884838067882(21)B2THVK, (01)00884838067882(21)B2ZN60, (01)00884838067882(21)F0DYMD, (01)00884838067882(21)F0DYMR, 010088483806788221F0G3JP, 010088483806788221F0G869, 010088483806788221F0G86F, 010088483806788221F0GCX4, (01)00884838061644(21)B25L78, (01)00884838061644(21)B25L7X, (01)00884838067882(21)B3XP02, (01)00884838061644(21)B1WDL1, (01)00884838067882(21)F083L7, (01)00884838067882(21)F0JDWK, (01)00884838061484(21)B28GVF, (01)00884838061484(21)F071WF, (01)04719873000043(21)B3L8J2, (01)04719873000043(21)B3W6FY, (01)04719873000043(21)F08BWB, (01)00884838067882(21)B32P1T, (01)00884838067882(21)B1RGL4, (01)00884838067882(21)B1RNKM, (01)0088483806788…
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-2373-2025 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.