AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
type: Dataset
description: FDA recall Z-0068-2026 — GE Medical Systems, SCS is recalling AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2 (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: AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
  type: MedicalDevice
  manufacturer: GE Medical Systems, SCS
claims: FDA recall Z-0068-2026: GE Medical Systems, SCS is recalling AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
claims: FDA classified recall Z-0068-2026 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0068-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0068-2026
      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: GE Medical Systems, SCS
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.
      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: UDI-DI 00840682102384 System IDs 907729AWS1 720238AW1 907ULMCCT 205934AWSRV 205975AWSRV 205971AWS 205510VAW 205815AWS2 UABMAWS1 749153GE3 UABMRPET 256593AW1 256265AWS4 256265AWS3 205481AWS1 251343AWS 251665MCIAWS 251316VAWS 251435AW5 251435AWSMARTSUB1 303584HP To be provided 251435AWSSMARTSUB1 256386AW1 205RCAWS 870423AWSMARTSUB1 870642AWS 718329SMART11 479314AWS1 479314AWS2 870207AW1 501686AWS31 501978AW1 501686AWSMARTSUB2 501552AW2 501202AWS1 501686AWSMARTSUB1 479338AWS 928773AWS 928214AWS 480256AWS 928757AWEN To be provided pacsaws01 To be provided 602344AWS 602651AWS 480342AWS 602277REVAW 480342AWSMARTSUB2 480342AWSMART1 480342AWSMART2 602344AWS1 602344SMARTAW 480342AWS2 602BUMC870 480342AWSMARTSUB3 928445AW1 06A6A668-AW-AWS_PRIMARY 844823AW1 844823AW 928283AWSMARTSUB1 520STJAWS 818RIAWSVR 661CHAWS 661KMCAWS 13123 13767 650696AWS To be provided 530UCVETAWSERV To be provided 760633HDCT To be provided 714FVAWSERVER 714FVDISC 510792AWH 559326AWS1 714447AWS AVHHFCTAW1 858657AWSMARTSUB2 858626AWS32 858824AWSMARTSUB2 858824SMARTSUB1 To be provided 909558SMART 805737AW2 562826AW46 9694 9693 323361AWSMARTSUB1 13256B To be provided 13526B 559353AW1 949367AWS 323BEVAWS 951704AWS 949764AWS 949764SMARTAW 510534AWS 510869AWSERV 510752AWS 916SUTABAWS 510437AWDL360 5496962AW11 510869APEX 760940AWS32 760940APEX 714771AWSRV 714456AWSMART 714456AW 650725AWS10 650725AWS30 650725AWSVM1 650725AWSVM2 650725AWSVM3 808341AW2 760446AWS 949278AW2 916SUTAWS 916SUTAWS2 916UCDAWS To be provided 858966SERVER 619532SERVER 9907 858657AWS32 858939EHLAWS 858626EHLAWS 858805AWSVM01 415600AWSERVER 415833AWSF 415476AWV 415MBCREV1 UCSFAWS4 UCSFAWS3 650725AWS20 408GSHOGEAW 408259EDCT 510784AWSERVER 9200 13195B 13196B 650696PET 805AWVM 310264AWS SHCGEAWSVM2 To be provided 818881AWSVR 805434AWS AWSHT1 310222HPAW 310823EHL1 310423EHL2 310423EHL1 To be provided 818782AWS1 To be provided 818676AW4 310423AWS 310423AWS2 To be provided 970544AWS 720848AWSRV 719365AWS DHAWSERV1 MCAAWSERV 303602AWS1 303DHREVCT…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Domestic US distribution nationwide. International distribution worldwide.
      status: recorded

FDA recall Z-0068-2026: GE Medical Systems, SCS is recalling AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
type: Claim
text: The FDA logged enforcement record Z-0068-2026: GE Medical Systems, SCS is voluntarily recalling AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2 — reason: Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-09-05. Affected lots/codes: UDI-DI 00840682102384 System IDs 907729AWS1 720238AW1 907ULMCCT 205934AWSRV 205975AWSRV 205971AWS 205510VAW 205815AWS2 UABMAWS1 749153GE3 UABMRPET 256593AW1 256265AWS4 256265AWS3 205481AWS1 251343AWS 251665MCIAWS 251316VAWS 251435AW5 251435AWSMARTSUB1 303584HP To be provided 251435AWSSMARTSUB1 256386AW1 205RCAWS 870423AWSMARTSUB1 870642AWS 718329SMART11 479314AWS1 479314AWS2 870207AW1 501686AWS31 501978AW1 501686AWSMARTSUB2 501552AW2 501202AWS1 501686AWSMARTSUB1 479338AWS 928773AWS 928214AWS 480256AWS 928757AWEN To be provided pacsaws01 To be provided 602344AWS 602651AWS 480342AWS 602277REVAW 480342AWSMARTSUB2 480342AWSMART1 480342AWSMART2 602344AWS1 602344SMARTAW 480342AWS2 602BUMC870 480342AWSMARTSUB3 928445AW1 06A6A668-AW-AWS_PRIMARY 844823AW1 844823AW 928283AWSMARTSUB1 520STJAWS 818RIAWSVR 661CHAWS 661KMCAWS 13123 13767 650696AWS To be provided 530UCVETAWSERV To be provided 760633HDCT To be provided 714FVAWSERVER 714FVDISC 510792AWH 559326AWS1 714447AWS AVHHFCTAW1 858657AWSMARTSUB2 858626AWS32 858824AWSMARTSUB2 858824SMARTSUB1 To be provided 909558SMART 805737AW2 562826AW46 9694 9693 323361AWSMARTSUB1 13256B To be provided 13526B 559353AW1 949367AWS 323BEVAWS 951704AWS 949764AWS 949764SMARTAW 510534AWS 510869AWSERV 510752AWS 916SUTABAWS 510437AWDL360 5496962AW11 510869APEX 760940AWS32 760940APEX 714771AWSRV 714456AWSMART 714456AW 650725AWS10 650725AWS30 650725AWSVM1 650725AWSVM2 650725AWSVM3 808341AW2 760446AWS 949278AW2 916SUTAWS 916SUTAWS2 916UCDAWS To be provided 858966SERVER 619532SERVER 9907 858657AWS32 858939EHLAWS…
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-0068-2026 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.