CMS8000 Patient Monitor
type: Dataset
description: FDA recall Z-1764-2025 — Contec Medical Systems Co., Ltd. is recalling CMS8000 Patient Monitor (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: CMS8000 Patient Monitor
  type: MedicalDevice
  manufacturer: Contec Medical Systems Co., Ltd.
claims: FDA recall Z-1764-2025: Contec Medical Systems Co., Ltd. is recalling CMS8000 Patient Monitor
claims: FDA classified recall Z-1764-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1764-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1764-2025
      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 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: Contec Medical Systems Co., Ltd.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Patient monitor has nine identified cybersecurity vulnerabilities.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2025-04-10
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: UDI-DI: 06945040100034. UDI-DI/Serial Numbers: AX1409100187, AX1410100001 AX1410100014 AX1410100015 AX1410100024 AX1410100028 AX1410100030 AX1410100036 AX1410100037 AX1410100038 AX1410100042 AX1410100044 AX1410100050 AX1410100059 AX1410100065 AX1410100074 AX1410100078 AX1410100079 AX1410100084 AX1410100087 AX1410100088 AX1410100092 AX1410100099 AX1410100101 AX1410100105 AX1410100107 AX1410100113 AX1410100117 AX1410100122 AX1410100127 AX1410100129 AX1410100136 AX1410100137 AX1410100141 AX1410100149 AX1410100153 AX1410100157 AX1410100160 AX1410100165 AX1410100168 AX1410100170 AX1410100172 AX1410100174 AX1410100187 AX1410100189 AX1410100195 AX1410100199 AX1411100003 AX1411100004 AX1411100006 AX1411100007 AX1411100008 AX1411100009 AX1411100011 AX1411100015 AX1411100018 AX1411100020 AX1411100024 AX1411100026 AX1411100027 AX1411100032 AX1411100038 AX1411100040 AX1411100042 AX1411100043 AX1411100044 AX1411100054 AX1411100057 AX1411100059 AX1411100066 AX1411100067 AX1411100073 AX1411100075 AX1411100076 AX1411100077 AX1411100079 AX1411100080 AX1411100084 AX1411100087 AX1411100089 AX1411100091 AX1411100093 AX1411100094 AX1411100096 AX1411100100 AX1411100101 AX1411100102 AX1411100107 AX1411100111 AX1411100112 AX1411100113 AX1411100114 AX1411100117 AX1411100120 AX1411100122 AX1411100123 AX1411100125 AX1411100126 AX1411100129 AX1411100130 AX1411100131 AX1411100134 AX1411100135 AX1411100137 AX1411100138 AX1411100140 AX1411100143 AX1411100145 AX1411100146 AX1411100148 AX1411100150 AX1411100151 AX1411100153 AX1411100154 AX1411100155 AX1411100156 AX1411100157 AX1411100161 AX1411100163 AX1411100164 AX1411100165 AX1411100171 AX1411100174 AX1411100175 AX1411100178 AX1411100179 AX1411100180 AX1411100181 AX1411100182 AX1411100183 AX1411100186 AX1411100188 AX1411100189 AX1411100190 AX1411100194 AX1411100196 AX1411100199 AX1410100058 AX1410100060 AX1410100062 AX1410100063 AX1410100064 AX1410100066 AX1410100067 AX1410100068 AX1410100069 AX1410100070 AX1410100071 AX1410100076 AX1410100081 AX…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide distribution in the states of CA, IL, FL, KY, TX.
      status: recorded

FDA recall Z-1764-2025: Contec Medical Systems Co., Ltd. is recalling CMS8000 Patient Monitor
type: Claim
text: The FDA logged enforcement record Z-1764-2025: Contec Medical Systems Co., Ltd. is voluntarily recalling CMS8000 Patient Monitor — reason: Patient monitor has nine identified cybersecurity vulnerabilities.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-04-10. Affected lots/codes: UDI-DI: 06945040100034. UDI-DI/Serial Numbers: AX1409100187, AX1410100001 AX1410100014 AX1410100015 AX1410100024 AX1410100028 AX1410100030 AX1410100036 AX1410100037 AX1410100038 AX1410100042 AX1410100044 AX1410100050 AX1410100059 AX1410100065 AX1410100074 AX1410100078 AX1410100079 AX1410100084 AX1410100087 AX1410100088 AX1410100092 AX1410100099 AX1410100101 AX1410100105 AX1410100107 AX1410100113 AX1410100117 AX1410100122 AX1410100127 AX1410100129 AX1410100136 AX1410100137 AX1410100141 AX1410100149 AX1410100153 AX1410100157 AX1410100160 AX1410100165 AX1410100168 AX1410100170 AX1410100172 AX1410100174 AX1410100187 AX1410100189 AX1410100195 AX1410100199 AX1411100003 AX1411100004 AX1411100006 AX1411100007 AX1411100008 AX1411100009 AX1411100011 AX1411100015 AX1411100018 AX1411100020 AX1411100024 AX1411100026 AX1411100027 AX1411100032 AX1411100038 AX1411100040 AX1411100042 AX1411100043 AX1411100044 AX1411100054 AX1411100057 AX1411100059 AX1411100066 AX1411100067 AX1411100073 AX1411100075 AX1411100076 AX1411100077 AX1411100079 AX1411100080 AX1411100084 AX1411100087 AX1411100089 AX1411100091 AX1411100093 AX1411100094 AX1411100096 AX1411100100 AX1411100101 AX1411100102 AX1411100107 AX1411100111 AX1411100112 AX1411100113 AX1411100114 AX1411100117 AX1411100120 AX1411100122 AX1411100123 AX1411100125 AX1411100126 AX1411100129 AX1411100130 AX1411100131 AX1411100134 AX1411100135 AX1411100137 AX1411100138 AX1411100140 AX1411100143 AX1411100145 AX1411100146 AX1411100148 AX1411100150 AX1411100151 AX1411100153 AX1411100154 AX1411100155 AX1411100156 AX1411100157 AX1411100161 AX1411100163 AX1411100164 AX1411100165 AX1411100171 AX1411100174 AX1411100175 AX1411100178 AX1411100179 AX1411…
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-1764-2025 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.