C5-2 Lumify Transducer Probe
type: Dataset
description: FDA recall Z-2354-2025 — Philips Ultrasound, Inc is recalling C5-2 Lumify 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: C5-2 Lumify Transducer Probe
  type: MedicalDevice
  manufacturer: Philips Ultrasound, Inc
claims: FDA recall Z-2354-2025: Philips Ultrasound, Inc is recalling C5-2 Lumify Transducer Probe
claims: FDA classified recall Z-2354-2025 as Class III
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2354-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2354-2025
      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. 989605450353, 989605450352, 989605477131, 989605450351, 989605451181, 989605427371; UDI: 010088483808517621F0FYRG, (01)00884838085176(21)B3H57K, (01)00884838068766(21)B1W1CR, (01)00884838086555(21)B2C7Z5, (01)00884838085176(21)F07VCW, (01)00884838085176(21)F0J0P8, (01)00884838061828(21)B1MBZM, (01)00884838068766(21)B1W1NG, (01)00884838085176(21)B1MC3H, (01)00884838085176(21)B1QHPM, (01)00884838085176(21)B1W13D, (01)00884838085176(21)B1W153, (01)00884838085176(21)B27BC5, (01)00884838085176(21)B3PH0F, (01)00884838085176(21)B3R48C, (01)00884838085176(21)F02N98, (01)00884838085176(21)F07PWD, (01)00884838085176(21)F07TZ0, (01)00884838085176(21)F07Y64, (01)00884838085176(21)F081Y3, (01)00884838085176(21)F082NG, (01)00884838085176(21)F082NP, (01)00884838085176(21)F0855V, (01)00884838085176(21)F088RF, (01)00884838085176(21)F089MZ, (01)00884838085176(21)F089N6, (01)00884838085176(21)F08GBG, (01)00884838085176(21)F08GBX, (01)00884838085176(21)F08HWH, (01)00884838085176(21)F08KFK, (01)00884838085176(21)F08NKZ, (01)00884838085176(21)F08NL0, (01)00884838085176(21)F08NLH, (01)00884838085176(21)F08PR7, (01)00884838085176(21)F08PR8, (01)00884838085176(21)F08PR9, (01)00884838085176(21)F08PRB, (01)00884838085176(21)F08PRF, (01)00884838085176(21)F08WGJ, (01)00884838085176(21)F08ZVL, (01)00884838085176(21)F091X3, (01)00884838085176(21)F091X6, (01)00884838085176(21)F091X8, (01)00884838085176(21)F091X9, (01)00884838085176(21)F092MC, (01)00884838085176(21)F092MG, (01)00884838085176(21)F0B6FV, (01)00884838085176(21)B3QQNQ, (01)00884838085176(21)F0JXYX, (01)00884838085176(21)F0K0WB, (01)00884838085176(21)B25WHM, (01)00884838085176(21)B25WJ0, (01)00884838085176(21)F03X7G, (01)00884838085176(21)F03Y09, (01)00884838085176(21)F03ZNR, (01)00884838086555(21)B2C81X, (01)00884838085176(21)F09WM3, (01)00884838086555(21)B2C805, (01)00884838085176(21)F00JK2, (01)00884838068766(21)B1QHC0, (01)00884838085176(21)F019V5, (01)00884838085176(21)F0D7WH, (01)00884838068766(21)B1W1QT, (01)00884838085…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide distribution.
      status: recorded

FDA recall Z-2354-2025: Philips Ultrasound, Inc is recalling C5-2 Lumify Transducer Probe
type: Claim
text: The FDA logged enforcement record Z-2354-2025: Philips Ultrasound, Inc is voluntarily recalling C5-2 Lumify 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. 989605450353, 989605450352, 989605477131, 989605450351, 989605451181, 989605427371; UDI: 010088483808517621F0FYRG, (01)00884838085176(21)B3H57K, (01)00884838068766(21)B1W1CR, (01)00884838086555(21)B2C7Z5, (01)00884838085176(21)F07VCW, (01)00884838085176(21)F0J0P8, (01)00884838061828(21)B1MBZM, (01)00884838068766(21)B1W1NG, (01)00884838085176(21)B1MC3H, (01)00884838085176(21)B1QHPM, (01)00884838085176(21)B1W13D, (01)00884838085176(21)B1W153, (01)00884838085176(21)B27BC5, (01)00884838085176(21)B3PH0F, (01)00884838085176(21)B3R48C, (01)00884838085176(21)F02N98, (01)00884838085176(21)F07PWD, (01)00884838085176(21)F07TZ0, (01)00884838085176(21)F07Y64, (01)00884838085176(21)F081Y3, (01)00884838085176(21)F082NG, (01)00884838085176(21)F082NP, (01)00884838085176(21)F0855V, (01)00884838085176(21)F088RF, (01)00884838085176(21)F089MZ, (01)00884838085176(21)F089N6, (01)00884838085176(21)F08GBG, (01)00884838085176(21)F08GBX, (01)00884838085176(21)F08HWH, (01)00884838085176(21)F08KFK, (01)00884838085176(21)F08NKZ, (01)00884838085176(21)F08NL0, (01)00884838085176(21)F08NLH, (01)00884838085176(21)F08PR7, (01)00884838085176(21)F08PR8, (01)00884838085176(21)F08PR9, (01)00884838085176(21)F08PRB, (01)00884838085176(21)F08PRF, (01)00884838085176(21)F08WGJ, (01)00884838085176(21)F08ZVL, (01)00884838085176(21)F091X3, (01)00884838085176(21)F091X6, (01)00884838085176(21)F091X8, (01)00884838085176(21)F091X9, (01)00884838085176(21)F092MC, (01)00884838085176(21)F092MG, (01)00884838085176(21)F0B6FV, (01)00884838085176(21)B3QQNQ, (01)00884838085176(21)F0JXYX, (01)00884838085176(21)F0K0WB, (01)00884838085176(21)B25WHM, (01)00884838085176(21)B25WJ0, (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-2354-2025 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.