GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, cathode ray tube
type: Dataset
description: FDA recall Z-0214-2026 — Wipro GE Healthcare Private Ltd. is recalling GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, cathode ray tube (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: GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, cathode ray tube
  type: MedicalDevice
  manufacturer: Wipro GE Healthcare Private Ltd.
claims: enforcement-record
claims: FDA classified recall Z-0214-2026 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0214-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0214-2026
      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: Wipro GE Healthcare Private Ltd.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software version V3.0.5, which can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of central stations connected to the network is 118, 119 or 120.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2025-09-05
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: GTIN 00195278343383, Serial Numbers: STV25225456SA, STV25225455SA, STV25266464SA, STV25235817SA, STV25235816SA, STV25286682SA, STV25225594SA, STV25235792SA, STV25235774SA, STV25225550SA, STV25235626SA, STV25235625SA, STV25184592SA, STV25235628SA, STV25235631SA, STV25184595SA, STV25235629SA, STV25235632SA, STV25235630SA, STV25276515SA, STV25225510SA, STV25276516SA, STV25225505SA, STV25225508SA, STV25225509SA, STV25225507SA, STV25225506SA, STV25113369SA, STV25204986SA, STV25205160SA, STV25205151SA, STV25205161SA, STV25062736SA, STV25256133SA, STV25225512SA, STV25296702SA, STV25296701SA, STV25296748SA, STV25256214SA, STV25225511SA, STV25256215SA, STV25256199SA, STV25256216SA, STV25256202SA, STV25225497SA, STV25225514SA, STV25225498SA, STV25256131SA, STV25256129SA, STV25256128SA, STV25296747SA, STV25256132SA, STV25256362SA, STV25225494SA, STV25225513SA, STV25296697SA, STV25256153SA, STV25296745SA, STV25256130SA, STV25256134SA, STV25256198SA, STV25296749SA, STV25296698SA, STV25256112SA, STV25256111SA, STV25225495SA, STV25256127SA, STV25256197SA, STV25296700SA, STV25296699SA, STV23440159SA, STV23440160SA, STV23440161SA, STV23440162SA, STV23440163SA, STV23440164SA, STV23440165SA, STV23440166SA, STV23440167SA, STV23440169SA, STV23440170SA, STV23440172SA, STV23440173SA, STV23440174SA, STV23440175SA, STV23440176SA, STV23440178SA, STV23440179SA, STV23440180SA, STV23440185SA, STV23440186SA, STV23440187SA, STV23440188SA, STV24250149SA, STV24250150SA, STV24250151SA, STV23440171SA, STV25184584SA, STV25174487SA, STV25256226SA, STV25256227SA, STV25256229SA, STV25256231SA, STV25256232SA, STV25256233SA, STV25256242SA, STV25256243SA, STV25256245SA, STV25256246SA, STV25256247SA, STV25256250SA, STV25256257SA, STV25256258SA, STV23450102SA, STV23450100SA, STV23450101SA, STV23450104SA, STV23450110SA, STV23450108SA, STV23450099SA, STV23450109SA, STV25266498SA, STV25266499SA, STV25184700SA, STV25194774SA, STV25194847SA, STV25194865SA, STV25194866SA, STV25194864SA, STV25194874SA, STV25194852SA…
      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-0214-2026: Wipro GE Healthcare Private Ltd. is recalling GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, cathode ray tube
text: The FDA logged enforcement record Z-0214-2026: Wipro GE Healthcare Private Ltd. is voluntarily recalling GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, cathode ray tube — reason: GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software version V3.0.5, which can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of central stations connected to the network is 118, 119 or 120.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-09-05. Affected lots/codes: GTIN 00195278343383, Serial Numbers: STV25225456SA, STV25225455SA, STV25266464SA, STV25235817SA, STV25235816SA, STV25286682SA, STV25225594SA, STV25235792SA, STV25235774SA, STV25225550SA, STV25235626SA, STV25235625SA, STV25184592SA, STV25235628SA, STV25235631SA, STV25184595SA, STV25235629SA, STV25235632SA, STV25235630SA, STV25276515SA, STV25225510SA, STV25276516SA, STV25225505SA, STV25225508SA, STV25225509SA, STV25225507SA, STV25225506SA, STV25113369SA, STV25204986SA, STV25205160SA, STV25205151SA, STV25205161SA, STV25062736SA, STV25256133SA, STV25225512SA, STV25296702SA, STV25296701SA, STV25296748SA, STV25256214SA, STV25225511SA, STV25256215SA, STV25256199SA, STV25256216SA, STV25256202SA, STV25225497SA, STV25225514SA, STV25225498SA, STV25256131SA, STV25256129SA, STV25256128SA, STV25296747SA, STV25256132SA, STV25256362SA, STV25225494SA, STV25225513SA, STV25296697SA, STV25256153SA, STV25296745SA, STV25256130SA, STV25256134SA, STV25256198SA, STV25296749SA, STV25296698SA, STV25256112SA, STV25256111SA, STV25225495SA, STV25256127SA, STV25256197SA, STV25296700SA, STV25296699SA, STV23440159SA, STV23440160SA, STV23440161SA, STV23440162SA, STV23440163SA, STV23440164SA, STV23440165SA, STV23440166SA, STV23440167SA, STV23440169SA, STV23440170SA, STV23440172SA, STV…
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-0214-2026 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.