Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
type: Dataset
description: FDA recall Z-0883-2026 — Philips Ultrasound, LLC is recalling Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841, (Devices, Class II). 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: Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
  type: MedicalDevice
  manufacturer: Philips Ultrasound, LLC
claims: FDA recall Z-0883-2026: Philips Ultrasound, LLC is recalling Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
claims: FDA classified recall Z-0883-2026 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0883-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0883-2026
      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 II
      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, LLC
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2025-10-31
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: UDI:700884838103405, 00884838120266, 00884838064713, 00884838108455 / Serial Numbers: USD21L1900 US122L0603 USD21L1901 USD21L1722 US122L1176 USD21L1720 US122L1175 US122L1186 US122L0415 US122L1174 USD21L1587 USD21L1586 USD21L1416 USD21L2073 USD21L1589 USD21L1721 US122L1177 US122L1305 US122L0996 USD21L1588 US122L1190 US122L1183 US122L0416 US122L1671 US122L0523 USD21L1719 US122L0522 US122L1048 USD21L1417 US122L1856 US122L1854 US122L1852 US122L1376 US122L1310 US122L0040 US122L1289 US122L1673 US122L0602 USD21L1590 US122L1307 USD21L2052 US122L1311 US122L0038 US122L1309 USO21L0079 US122L1855 USO21L0048 US921L1762 USO21L0046 USO21L0017 USO21L1376 US921L1485 USO21L0045 US921L1331 US921L1694 USO21L0038 USO21L0039 US921L1761 USO21L0040 US921L1760 US921L1759 US921L1695 US921L1609 USO21L0044 USO21L0078 USO21L0050 USO21L0015 US921L1610 USO21L0003 USO21L0043 US921L1484 USO21L1495 USO21L0093 USO21L1374 USO21L1373 USO21L1755 USO21L0081 USO21L0119 USO21L1667 USO21L0579 USO21L0083 USD21L2046 USO21L1375 USO21L0042 US921L1330 USO21L0041 US921L1693 USO21L0036 USO21L1753 USO21L0049 USO21L0037 US921L1696 USO21L0016 USO21L0047 USO21L0764 USO21L0080 USD21L2054 USD21L0049 USD21L0036 USD21L0037 USO21L0082 USD21L2049 USD21L2055 USD21L2051 USD21L2047 USD21L2239 USD21L0055 USD21L2153 USD21L0068 US122L0037 USD21L0039 USD21L0053 USD21L0056 US622L0962 USD21L0040 USD21L2048 USO21L0578 USD21L0050 USD21L0051 USD21L0052 USD21L0066 USD21L0704 USD21L0054 USD21L0524 US821L0816 US821L0583 US821L0586 US821L0246 US821L0585 US821L0582 US821L0580 US821L0347 US821L0587 US821L0581 US821L0584 US821L0420 US821L0473 US821L0101 US821L0099 US821L0100 US821L0098 US621L2293 US621L2144 US721L0342 US621L2051 US621L1995 US621L2053 US621L2050 US721L0807 US621L2054 US621L2049 US721L0530 US721L0406 US621L2057 US721L0529 US621L1997 US721L0404 US721L0528 US621L2056 US721L0395 US621L2058 US721L0803 US721L0397 US721L0804 US621L2055 US621L2052 US621L1996 US721L0808 US721L0403 US721L0396 US721L0805 US721L0398 US721L0405 US721L0159 …
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR and the countries of Argentina, Armenia, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Dominican Rep, Ecuador, El Salvador, Estonia, France, Germany, Greece, Guatemala, Honduras , Hungary, Iceland, India, Indonesia, Israel, Italy, Jordan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Singapore, Slovakia, South Africa, South Korea, Spain, St. Pier/Miquel., Sweden, Switzerland, Taiwan, Thailand, Trinidad/Tobago, Tunisia, T¿rkiye, United Kingdom, Uruguay, Vietnam.
      status: recorded

FDA recall Z-0883-2026: Philips Ultrasound, LLC is recalling Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
type: Claim
text: The FDA logged enforcement record Z-0883-2026: Philips Ultrasound, LLC is voluntarily recalling Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841, — reason: Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-10-31. Affected lots/codes: UDI:700884838103405, 00884838120266, 00884838064713, 00884838108455 / Serial Numbers: USD21L1900 US122L0603 USD21L1901 USD21L1722 US122L1176 USD21L1720 US122L1175 US122L1186 US122L0415 US122L1174 USD21L1587 USD21L1586 USD21L1416 USD21L2073 USD21L1589 USD21L1721 US122L1177 US122L1305 US122L0996 USD21L1588 US122L1190 US122L1183 US122L0416 US122L1671 US122L0523 USD21L1719 US122L0522 US122L1048 USD21L1417 US122L1856 US122L1854 US122L1852 US122L1376 US122L1310 US122L0040 US122L1289 US122L1673 US122L0602 USD21L1590 US122L1307 USD21L2052 US122L1311 US122L0038 US122L1309 USO21L0079 US122L1855 USO21L0048 US921L1762 USO21L0046 USO21L0017 USO21L1376 US921L1485 USO21L0045 US921L1331 US921L1694 USO21L0038 USO21L0039 US921L1761 USO21L0040 US921L1760 US921L1759 US921L1695 US921L1609 USO21L0044 USO21L0078 USO21L0050 USO21L0015 US921L1610 USO21L0003 USO21L0043 US921L1484 USO21L1495 USO21L0093 USO21L1374 USO21L1373 USO21L1755 USO21L0081 USO21L0119 USO21L1667 USO21L0579 USO21L0083 USD21L2046 USO21L1375 USO21L0042 US921L1330 USO21L0041 US921L1693 USO21L0036 USO21L1753 USO21L0049 USO21L0037 US921L1696 USO21L0016 USO21L0047 USO21L0764 USO21L0080 USD21L2054 USD21L0049 USD21L0036 USD21L0037 USO21L0082 USD21L2049 USD21L2055 USD21L2051 USD21L2047 USD21L2239 USD21L0055 USD21L2153 USD21L0068 US122L0037 USD21L0039 USD21L0053 USD21L0056 US622L0962 USD21L0040 USD21L2048 USO21L0578 USD21L0050 USD21L0051 USD21L0052 USD21L0066 USD21L0704 USD21L0054 USD21L0524 US821L0816 US821L0583 US821L0586 US821L0246 US821L0585 US821L0582 US821L0580 US821L0347 US821L0587 US821L0581 US821L0584 US821L0420 US821L0473 US82…
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-0883-2026 as Class II
type: Claim
text: The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious 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 II
  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.