GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system.
type: Dataset
description: FDA recall Z-1628-2025 — GE Medical Systems China Co., Ltd. is recalling GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system. (Devices, Class I). 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 CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system.
  type: MedicalDevice
  manufacturer: GE Medical Systems China Co., Ltd.
claims: FDA recall Z-1628-2025: GE Medical Systems China Co., Ltd. is recalling GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system.
claims: FDA classified recall Z-1628-2025 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1628-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1628-2025
      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 I
      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 Medical Systems China Co., Ltd.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2025-03-21
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: GTIN 00840682103947, Serial Numbers: SM724310010MA, SM723370006MA, SM723080015MA, SM724440001MA, SM723370003MA, SM723240009MA, SM723360010MA, SM723360011MA, SM723360012MA, SM723360013MA, SM723360014MA, SM723360015MA, SM723360016MA, SM723360017MA, SM724100019MA, SM724500002MA, SM724500003MA, SM724500004MA, SM724500005MA, SM723370008MA, SM724140005MA, SM723370002MA, SM723370004MA, SM723370005MA, SM723370007MA, SM723020044MA, SM723020045MA, SM723020046MA, SM723050009MA, SM723050010MA, SM723370001MA, SM725060005MA, SM724480001MA, SM724390036MA, SM724390037MA, SM724150044MA, SM724300003MA, SM724300004MA, SM724390010MA, SM725040006MA, SM725040007MA, SM725040008MA, SM724150023MA, SM724150024MA, SM723370009MA, SM724200001MA, SM724250009MA, SM725050005MA, SM724490002MA, SM723440001MA, SM723020034MA, SM723030003MA, SM723030004MA, SM723030032MA, SM724390006MA, SM724390007MA, SM724390008MA, SM723020029MA, SM723020030MA, SM724370011MA, SM724460002MA, SM723170023MA, SM723170024MA, SM723240007MA, SM723240008MA, SM723240010MA, SM723240011MA, SM723240012MA, SM723240013MA, SM725020001MA, SM724010037MA, SM724010038MA, SM724010039MA, SM724250029MA, SM724190144MA, SM724190145MA, SM724190146MA, SM724190147MA, SM724190148MA, SM724190149MA, SM723040004MA, SM723040005MA, SM723040006MA, SM723040007MA, SM723040008MA, SM724400004MA, SM724400005MA, SM724400006MA, SM724400007MA, SM724360001MA, SM724360002MA, SM723160001MA, SM724140024MA, SM724140025MA, SM724140026MA, SM724140027MA, SM724320016MA, SM723310001MA, SM723260014MA, SM724150025MA, SM724150026MA, SM724150027MA, SM723120001MA, SM724110014MA, SM723260011MA, SM724440002MA, SM724440003MA, SM723120012MA, SM723120013MA, SM723120014MA, SM723120015MA, SM723120016MA, SM723490002MA, SM723490003MA, SM723500021MA, SM723300024MA, SM723300025MA, SM723300026MA, SM723300027MA, SM723300028MA, SM723260008MA, SM723260009MA, SM723260010MA, SM724200017MA, SM724200018MA, SM724200019MA, SM723240006MA, SM724210001MA, SM723160016MA, SM724150048MA, SM724150049MA…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide distribution. US nationwide including Puerto Rico, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Fiji, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Maldives, Malta, Mexico, Moldova, Montenegro, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Oman, Pakistan, State of Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tonga, Trinidad Tobago, Tunisia, T¿rkiye, Uganda, Ukraine, UAE, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.
      status: recorded

FDA recall Z-1628-2025: GE Medical Systems China Co., Ltd. is recalling GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system.
type: Claim
text: The FDA logged enforcement record Z-1628-2025: GE Medical Systems China Co., Ltd. is voluntarily recalling GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system. — reason: Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-03-21. Affected lots/codes: GTIN 00840682103947, Serial Numbers: SM724310010MA, SM723370006MA, SM723080015MA, SM724440001MA, SM723370003MA, SM723240009MA, SM723360010MA, SM723360011MA, SM723360012MA, SM723360013MA, SM723360014MA, SM723360015MA, SM723360016MA, SM723360017MA, SM724100019MA, SM724500002MA, SM724500003MA, SM724500004MA, SM724500005MA, SM723370008MA, SM724140005MA, SM723370002MA, SM723370004MA, SM723370005MA, SM723370007MA, SM723020044MA, SM723020045MA, SM723020046MA, SM723050009MA, SM723050010MA, SM723370001MA, SM725060005MA, SM724480001MA, SM724390036MA, SM724390037MA, SM724150044MA, SM724300003MA, SM724300004MA, SM724390010MA, SM725040006MA, SM725040007MA, SM725040008MA, SM724150023MA, SM724150024MA, SM723370009MA, SM724200001MA, SM724250009MA, SM725050005MA, SM724490002MA, SM723440001MA, SM723020034MA, SM723030003MA, SM723030004MA, SM723030032MA, SM724390006MA, SM724390007MA, SM724390008MA, SM723020029MA, SM723020030MA, SM724370011MA, SM724460002MA, SM723170023MA, SM723170024MA, SM723240007MA, SM723240008MA, SM723240010MA, SM723240011MA, SM723240012MA, SM723240013MA, SM725020001MA, SM724010037MA, SM724010038MA, SM724010039MA, SM724250029MA, SM724190144MA, SM724190145MA, SM724190146MA, SM724190147MA, SM724190148MA, SM724190149MA, SM723040004MA, SM723040005MA, SM723040006MA, SM723040007MA, SM723040008MA, SM724400004MA, SM724400005MA, SM724400006MA…
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-1628-2025 as Class I
type: Claim
text: The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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 I
  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.