Z-2733-2024.jsonld
type: Dataset
name: GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available
description: FDA recall Z-2733-2024 — GE Healthcare (China) Co., Ltd. is recalling GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available (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 Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available
  manufacturer: GE Healthcare (China) Co., Ltd.
claims: enforcement-record
claims: FDA classified recall Z-2733-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2733-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2733-2024
      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 (China) Co., Ltd.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for de-installing the devices. De-installation instruction process steps must be followed when de-installing these devices to avoid personnel injury during de-install.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-07-12
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: 1) 2259973: UDI/DI none: System ID Numbers: 918485PROT1, 281410PRO; UDI/DI 00840682120777: System ID Number 503315PRO; 2) 2259988: UDI/DI 00840682106139: System ID Numbers: 305682PROTEUS, 305MCPCPRO, 828262PROT, 631376ER2, 716675DPRO1, 206965XR; UDI/DI 00840682120777: System ID Numbers: 251435PROT, 334418PRO, 334418XRA, 520MERPRO, 805652DR2, 303320TPXR, 970248PROT, 203732PROT, 203876XRA564, 941792PROTEUS, 305CGHPROTEUS, 561495RAD1, 850837PROTEUS, 352FRIPRO, 386LCMCER1, 813344PROTXR, 561881ICRAD, 850469PROT, 561655XRA, FWR1453, 478289PRO, 847298AMGPROT, 630225NWMGE02PXRA, 630225NWMGEO1D, 630241PROT, 317439PROT, 317338SPORTS, 317773PROT, 317204PROT, 913491PROXR1, 620421PRO1, 785543PRO, 785743PRO, 598761NVP, 906483XRA564, 313745RERPROT, 1000001522, 601855PROTEUS, 662773RAD1, 662756PRO, 704323FA, 704323PROS, 908237RAD, 201656PROT, 575439PROT, 585227PRO1, 914964PROT, 740HVCHPRO, 740333PROT1, 740FAYPRO, 724547XR1, 864512KCPROT, 843681PROTEUS, 843839XR, 901767PROTXR, 737202PROT, SDNAMCTRAUMA, 281897XRPRO, 254751PROLL, 512SDMCLER, 254751XRA, 804TRIPRO, 804285PRO1, 804285PRO2, 540970ER, 360475PSNSPROT, 509674CEX1, 920907PROT1, 414529PRO1, 608785PROTBEL, 414385PRO1, 414978PRO, 414570PRO1, 920303PROT1, 262542PROXRA, 414479PRO4, 414607PROXR1, 905732RAD2, RU8366RX01, ZA2985RX01, 34442RAD01, XR1383UY; UDI/DI none: System ID Numers: 907842PROTX, 907796ORTHO, 907796PROT, 907443PROTEUS, 907861VER, 256235ORT1, 251368ARAD, 205481PRO, 205592DCPRO, 251847RAD, 205280PRO, 256737PRO, 251435R1, 251275RAD, 256486XR1, 256429CR2, 256782PRO1, 205387PRO, 256CCP1, 256974PR1, 334732PXRA, 256332RRM1, 256356RAD1, 256386RM4, 334670RAD, 205750RAD, 256487RAD, 870898PROT, 479BVXR, 479709PROT, 870816PROT, 501622PROT, 870972PRO1, 870972PRO2, 870245PROT, GON4605254, 870508BJC1, 870845PROT2, 501202BNLER, 870541PROT6, 479338PROT1, 501268PROT2, 870673PROT, 870226PROT, 870208RF, 870208XR1, 623925XR1, 480FCCHDXR, 480MAYOXR, DAZGHCHD2XR, 480603XR1, 520228PRO, 520533PRO1, 928758RAD, 480984XR1, 623433XR1, 623FCGLE…
      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-2733-2024: GE Healthcare (China) Co., Ltd. is recalling GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available
text: The FDA logged enforcement record Z-2733-2024: GE Healthcare (China) Co., Ltd. is voluntarily recalling GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available — reason: The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for de-installing the devices. De-installation instruction process steps must be followed when de-installing these devices to avoid personnel injury during de-install.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-07-12. Affected lots/codes: 1) 2259973: UDI/DI none: System ID Numbers: 918485PROT1, 281410PRO; UDI/DI 00840682120777: System ID Number 503315PRO; 2) 2259988: UDI/DI 00840682106139: System ID Numbers: 305682PROTEUS, 305MCPCPRO, 828262PROT, 631376ER2, 716675DPRO1, 206965XR; UDI/DI 00840682120777: System ID Numbers: 251435PROT, 334418PRO, 334418XRA, 520MERPRO, 805652DR2, 303320TPXR, 970248PROT, 203732PROT, 203876XRA564, 941792PROTEUS, 305CGHPROTEUS, 561495RAD1, 850837PROTEUS, 352FRIPRO, 386LCMCER1, 813344PROTXR, 561881ICRAD, 850469PROT, 561655XRA, FWR1453, 478289PRO, 847298AMGPROT, 630225NWMGE02PXRA, 630225NWMGEO1D, 630241PROT, 317439PROT, 317338SPORTS, 317773PROT, 317204PROT, 913491PROXR1, 620421PRO1, 785543PRO, 785743PRO, 598761NVP, 906483XRA564, 313745RERPROT, 1000001522, 601855PROTEUS, 662773RAD1, 662756PRO, 704323FA, 704323PROS, 908237RAD, 201656PROT, 575439PROT, 585227PRO1, 914964PROT, 740HVCHPRO, 740333PROT1, 740FAYPRO, 724547XR1, 864512KCPROT, 843681PROTEUS, 843839XR, 901767PROTXR, 737202PROT, SDNAMCTRAUMA, 281897XRPRO, 254751PROLL, 512SDMCLER, 254751XRA, 804TRIPRO, 804285PRO1, 804285PRO2, 540970ER, 360475PSNSPROT, 509674CEX1, 920907PROT1, 414529PRO1, 608785PROTBEL, 414385PRO1, 414978PRO, 414570PRO1, 920303PROT1, 262542PROXRA, 414479PRO4, 414607PROXR1, 905732RAD2, RU8366RX01, ZA2985RX01, 34442RAD01, X…
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-2733-2024 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.