Z-1486-2025.jsonld
type: Dataset
name: GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8) 2109571-010; 9) 2109571-011; 10) 2109571-012; 11) MANLEGACY111; 12) MANLEGACY112; 13) MANLEGACY47; 14) P00011TS.
description: FDA recall Z-1486-2025 — GE Healthcare is recalling GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8) 2109571-010; 9) 2109571-011; 10) 2109571-012; 11) MANLEGACY111; 12) MANLEGACY112; 13) MANLEGACY47; 14) P00011TS. (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: GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8) 2109571-010; 9) 2109571-011; 10) 2109571-012; 11) MANLEGACY111; 12) MANLEGACY112; 13) MANLEGACY47; 14) P00011TS.
  manufacturer: GE Healthcare
claims: enforcement-record
claims: FDA classified recall Z-1486-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1486-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1486-2025
      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: GE Healthcare
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2025-02-19
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: Model/Catalog/Code # 2033901-001, Installed Product ID 14335625-Centricity CA1000-19675863, UDI UDI Not Required, System ID HCIT4082079CA1000; Model/Catalog/Code # 2038437-001, Installed Product ID 11558-1-Centricity CA1000-00099550, UDI UDI Not Required, System ID 520855CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103987-1-Centricity CA1000-00102841, UDI UDI Not Required, System ID 928537CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 9990-1-Centricity CA1000-00101135, UDI UDI not required, System ID 661327CWS01; Model/Catalog/Code # 2038437-001, Installed Product ID 10318-1-Centricity CA1000-00105877, UDI UDI not required, System ID 818397CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10994-1-Centricity CA1000-00102387, UDI UDI Not required, System ID 909464CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 102131-1-Centricity CA1000-00105886, UDI UDI not required, System ID 818409CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 4161-1-Centricity CA1000-00105894, UDI UDI Not Required, System ID 818502CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103743-1-Centricity CA1000-00099665, UDI UDI Not Required, System ID 559582CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 4408-2-Centricity CA1000-00101725, UDI UDI not required, System ID 714843CA1000; Model/Catalog/Code # 2038437-001, Installed Product ID 4532-4-Centricity CA1000-00107356, UDI UDI Not Required, System ID 310673CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 4009-2-Centricity CA1000-00100791, UDI UDI not required, System ID 619260CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 1354-8-Centricity CA1000-00102389, UDI UDI not required, System ID 909558CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 9927-2-Centricity CA1000-00099762, UDI UDI not required, System ID 562491CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 11299-9-Centricity CA1000-…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide distribution.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-1486-2025: GE Healthcare is recalling GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8) 2109571-010; 9) 2109571-011; 10) 2109571-012; 11) MANLEGACY111; 12) MANLEGACY112; 13) MANLEGACY47; 14) P00011TS.
text: The FDA logged enforcement record Z-1486-2025: GE Healthcare is voluntarily recalling GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8) 2109571-010; 9) 2109571-011; 10) 2109571-012; 11) MANLEGACY111; 12) MANLEGACY112; 13) MANLEGACY47; 14) P00011TS. — reason: There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-02-19. Affected lots/codes: Model/Catalog/Code # 2033901-001, Installed Product ID 14335625-Centricity CA1000-19675863, UDI UDI Not Required, System ID HCIT4082079CA1000; Model/Catalog/Code # 2038437-001, Installed Product ID 11558-1-Centricity CA1000-00099550, UDI UDI Not Required, System ID 520855CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103987-1-Centricity CA1000-00102841, UDI UDI Not Required, System ID 928537CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 9990-1-Centricity CA1000-00101135, UDI UDI not required, System ID 661327CWS01; Model/Catalog/Code # 2038437-001, Installed Product ID 10318-1-Centricity CA1000-00105877, UDI UDI not required, System ID 818397CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10994-1-Centricity CA1000-00102387, UDI UDI Not required, System ID 909464CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 102131-1-Centricity CA1000-00105886, UDI UDI not required, System ID 818409CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 4161-1-Centricity CA1000-00105894, UDI UDI Not Required, System ID 818502CA1SW1; Model/Catalog/Code # 2038437-001, …
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-1486-2025 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.