MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4
type: Dataset
description: FDA recall Z-0231-2026 — GE Medical Systems, LLC is recalling MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4 (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: MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4
  type: MedicalDevice
  manufacturer: GE Medical Systems, LLC
claims: enforcement-record
claims: FDA classified recall Z-0231-2026 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0231-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0231-2026
      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, LLC
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2025-08-22
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: UDI-DI: 00840682125499; Serial Numbers: VU221240028SA VU221250168SA VU222120101SA VU222120114SA VU222120120SA VU222400056SA VU222400070SA VU222480182SA VU421010035SA VU420530073SA VU420530105SA VU420530108SA VU420530109SA VU420530110SA VU421010007SA VU421010008SA VU421010009SA VU421010010SA VU421010012SA VU421010021SA VU421010029SA VU421010040SA VU421010042SA VU422410219SA VU422410220SA VU220500166SA VU220500167SA VU222250167SA VU222250175SA VU423290038SA VU423290039SA VU423290063SA VU423290068SA VU221500205SA VU221500215SA VU221500216SA VU221500218SA VU221300012SA VU221320090SA VU221330009SA VU221330012SA VU221330013SA VU221120005SA VU221490009SA VU221490015SA VU221490031SA VU221490033SA VU221490038SA VU221490043SA VU221490113SA VU421250084SA VU420290004SA VU420290052SA VU221350037SA VU421340025SA VU421340038SA VU421340117SA VU421340120SA VU421340127SA VU421340131SA VU421340139SA VU421340142SA VU421340163SA VU421350169SA VU421350174SA VU421350179SA VU421350201SA VU421350206SA VU421350207SA VU421350209SA VU421350210SA VU421350211SA VU421350213SA VU421350214SA VU421350216SA VU421350223SA VU421350225SA VU421350227SA VU421350228SA VU421350231SA VU421350233SA VU421350239SA VU421350248SA VU421350249SA VU421350251SA VU421350252SA VU421350253SA VU421350267SA VU421350268SA VU421350269SA VU421350271SA VU421350272SA VU421350273SA VU421350275SA VU421350279SA VU421350280SA VU421350282SA VU421350287SA VU421500058SA VU221010086SA VU221010089SA VU221020043SA VU221020044SA VU221020046SA VU221020047SA VU221020048SA VU221020051SA VU221020052SA VU221020054SA VU221020055SA VU221020056SA VU220100042SA VU220100050SA VU220100051SA VU220100055SA VU220100069SA VU220100073SA VU220100074SA VU220100076SA VU220100077SA VU220100079SA VU220100080SA VU220100082SA VU222390186SA VU221490003SA VU221490006SA VU221490010SA VU221490011SA VU221490012SA VU221490013SA VU221490014SA VU221490016SA VU221490021SA VU221490024SA VU221490029SA VU221490044SA VU221110086SA VU221040087SA VU222010022SA VU222010074SA …
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide Distribution: US (nationwide) and OUS (foreign/Global) to countries of: Australia, Austria, Bahrain, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Republic of, Kuwait, Malaysia, Netherlands, New Zealand, Norway, Philippines, Puerto Rico, Qatar, Saudi Arabia, Singapore, Sweden, Switzerland, Thailand, United Arab Emirates, and United Kingdom.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-0231-2026: GE Medical Systems, LLC is recalling MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4
text: The FDA logged enforcement record Z-0231-2026: GE Medical Systems, LLC is voluntarily recalling MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4 — reason: If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-08-22. Affected lots/codes: UDI-DI: 00840682125499; Serial Numbers: VU221240028SA VU221250168SA VU222120101SA VU222120114SA VU222120120SA VU222400056SA VU222400070SA VU222480182SA VU421010035SA VU420530073SA VU420530105SA VU420530108SA VU420530109SA VU420530110SA VU421010007SA VU421010008SA VU421010009SA VU421010010SA VU421010012SA VU421010021SA VU421010029SA VU421010040SA VU421010042SA VU422410219SA VU422410220SA VU220500166SA VU220500167SA VU222250167SA VU222250175SA VU423290038SA VU423290039SA VU423290063SA VU423290068SA VU221500205SA VU221500215SA VU221500216SA VU221500218SA VU221300012SA VU221320090SA VU221330009SA VU221330012SA VU221330013SA VU221120005SA VU221490009SA VU221490015SA VU221490031SA VU221490033SA VU221490038SA VU221490043SA VU221490113SA VU421250084SA VU420290004SA VU420290052SA VU221350037SA VU421340025SA VU421340038SA VU421340117SA VU421340120SA VU421340127SA VU421340131SA VU421340139SA VU421340142SA VU421340163SA VU421350169SA VU421350174SA VU421350179SA VU421350201SA VU421350206SA VU421350207SA VU421350209SA VU421350210SA VU421350211SA VU421350213SA VU421350214SA VU421350216SA VU421350223SA VU421350225SA VU421350227SA VU421350228SA VU421350231SA VU421350233SA VU421350239SA VU421350248SA VU421350249SA VU421350251SA VU421350252SA VU421350253SA VU421350267SA VU421350268SA …
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-0231-2026 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.