Z-1148-2026.jsonld
type: Dataset
name: Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (hereinafter called X series) can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. Component: No
description: FDA recall Z-1148-2026 — Edan Diagnostics is recalling Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (hereinafter called X series) can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. Component: No (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: MedicalDevice
  name: Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (hereinafter called X series) can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. Component: No
  manufacturer: Edan Diagnostics
claims: enforcement-record
claims: FDA classified recall Z-1148-2026 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1148-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1148-2026
      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: Edan Diagnostics
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2025-10-24
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: EDAN Model: X8 UDI-DI code: 06944413810907 Serial/Lot Numbers: 261586-M21116620010 261586-M21116620002 261586-M21116620007 261586-M21116620006 261586-M21116620009 261586-M21116630001 261586-M21116620008 261586-M21116620003 261586-M21116630005 261586-M21116630003 261586-M21116620004 261586-M21116620001 261586-M21116630004 261586-M21116630002 261586-M21116620005 261586-M21301970003 261586-M21301970004 261586-M21301960001 261586-M21301970005 261586-M21301960003 261586-M21301970002 261586-M21301970001 261586-M21301960002 261586-M21714500002 261586-M21714500001 261586-M21714500003 261586-M21816750005 261586-M21816750003 261586-M21816750002 261586-M21816750004 261586-M21816750001 261586-M22105750001 261586-M22105750007 261586-M22105750008 261586-M22105750010 261586-M22105750002 261586-M22105750005 261586-M22105750009 261586-M22105750006 261586-M22105750003 261586-M22105750004 261586-M22405430007 261586-M22405430001 261586-M22405430004 261586-M22405430010 261586-M22405430006 261586-M22405430009 261586-M22405430008 261586-M22405430003 261586-M22405430002 261586-M22405430005 261586-M22615270004 261586-M22615270005 261586-M22615270001 261586-M22615270002 261586-M22615270003 261586-M23226950003 261586-M23226950002 261586-M23226950004 261586-M23226950005 261586-M23226950001 261586-M23B18320003 261586-M23B18320004 261586-M23B18330001 261586-M23B18330002 261586-M23B18330003 261586-M23B18330004 261586-M23B18320001 261586-M23B18320005 261586-M23B18330005 261586-M23B18320002 261586-M23C15910003 261586-M23C15920001 261586-M23C15920005 261586-M23C15920004 261586-M23C15920009 261586-M23C15910002 261586-M23C15920010 261586-M23C15920002 261586-M23C15910001 261586-M23C15910005 261586-M23C15920006 261586-M23C15920003 261586-M23C15910004 261586-M23C15920008 261586-M23C15920007 261586-M24104080002 261586-M24104080010 261586-M24104080003 261586-M24104080004 261586-M24104080006 261586-M24104080001 261586-M24104080005 261586-M24104080008 261586-M24104080009 261586-M24104080007 261586-M206115900…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-1148-2026: Edan Diagnostics is recalling Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (hereinafter called X series) can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. Component: No
text: The FDA logged enforcement record Z-1148-2026: Edan Diagnostics is voluntarily recalling Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (hereinafter called X series) can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. Component: No — reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-10-24. Affected lots/codes: EDAN Model: X8 UDI-DI code: 06944413810907 Serial/Lot Numbers: 261586-M21116620010 261586-M21116620002 261586-M21116620007 261586-M21116620006 261586-M21116620009 261586-M21116630001 261586-M21116620008 261586-M21116620003 261586-M21116630005 261586-M21116630003 261586-M21116620004 261586-M21116620001 261586-M21116630004 261586-M21116630002 261586-M21116620005 261586-M21301970003 261586-M21301970004 261586-M21301960001 261586-M21301970005 261586-M21301960003 261586-M21301970002 261586-M21301970001 261586-M21301960002 261586-M21714500002 261586-M21714500001 261586-M21714500003 261586-M21816750005 261586-M21816750003 261586-M21816750002 261586-M21816750004 261586-M21816750001 261586-M22105750001 261586-M22105750007 261586-M22105750008 261586-M22105750010 261586-M22105750002 261586-M22105750005 261586-M22105750009 261586-M22105750006 261586-M22105750003 261586-M22105750004 261586-M22405430007 261586-M22405430001 261586-M22405430004 261586-M22405430010 261586-M22405430006 261586-M22405430009 261586-M22405430008 261586-M22405430003 261586-M22405430002 261586-M22405430005 261586-M22615270004 261586-M22615270005 261586-M22615270001 261586-M22615270002 261586-M22615270003 261586-M23…
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-1148-2026 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.