Z-1321-2025.jsonld
type: Dataset
name: Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas.
description: FDA recall Z-1321-2025 — ZOLL Medical Corporation is recalling Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas. (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: Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas.
  manufacturer: ZOLL Medical Corporation
claims: enforcement-record
claims: FDA classified recall Z-1321-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1321-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1321-2025
      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 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: ZOLL Medical Corporation
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2025-02-13
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: Model/Catalog Number: G5S-80C; UDI-DI: 00812394021284; Serial Numbers: D00000171086, D00000171087, D00000171088, D00000171089, D00000171090, D00000171092, D00000171093, D00000171094, D00000171095, D00000171096, D00000171097, D00000171098, D00000171099, D00000171100, D00000171101, D00000171102, D00000171103, D00000171105, D00000171107, D00000171109, D00000171111, D00000171113, D00000171115, D00000171117, D00000171118, D00000171121, D00000171126, D00000171133, D00000171134, D00000171136, D00000171138, D00000171140, D00000171144, D00000171147, D00000171150, D00000171154, D00000171157, D00000171159, D00000171160, D00000171164, D00000171165, D00000171166, D00000171167, D00000171168, D00000171169, D00000171170, D00000171171, D00000171172, D00000171178, D00000171179, D00000171181, D00000171183, D00000171186, D00000171188, D00000171190, D00000171601, D00000172373, D00000172376, D00000172379, D00000172381, D00000172382, D00000172383, D00000172384, D00000172385, D00000172386, D00000172391, D00000172412, D00000172413, D00000172414, D00000172416, D00000172421, D00000172422, D00000172425, D00000172426, D00000172428, D00000172430, D00000172431, D00000172432, D00000172433, D00000172434, D00000172435, D00000172436, D00000172437, D00000172438, D00000172439, D00000172444, D00000172446, D00000172448, D00000172449, D00000172455, D00000172466, D00000172473, D00000172482, D00000172483, D00000172484, D00000172486, D00000172487, D00000172488, D00000172489, D00000172493, D00000172497, D00000172503, D00000172506, D00000172563, D00000172565, D00000172571, D00000172572, D00000172583, D00000172589, D00000172592, D00000172616, D00000172742, D00000172985, D00000172991, D00000172999, D00000173001, D00000173008, D00000173019, D00000173025, D00000173043, D00000173048, D00000173050, D00000173056, D00000173057, D00000173061, D00000173062, D00000173067, D00000173068, D00000173069, D00000173070, D00000173071, D00000173074, D00000173079, D00000173091, D00000173093, D00000173094, D00000173095, D0000017309…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Domestic: Nationwide Distribution International: AE, AI, AM, AR, AT, AU, BD, BE, BG, BH, BM, BN, BS, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DO, EG, ES, FI, FR, GB, GH, GU, HK, HR, HU, ID, IE, IL, IN, IS, IT, JE, JM, JP, KR, KW, KZ, LB, LT, MA, MC, MD, ME, MQ, MS, MT, MX, MY, NC, NG, NL, NO, NZ, OM, PA, PE, PG, PH, PK, PL, PR, PT, QA, RE, RO, RS, RU, SA, SE, SG, SI, SK, SM, TC, TH, TN, TR, TW, UA, US, VG, ZA.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-1321-2025: ZOLL Medical Corporation is recalling Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas.
text: The FDA logged enforcement record Z-1321-2025: ZOLL Medical Corporation is voluntarily recalling Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas. — reason: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).. Status: Ongoing — the recall is still being carried out.. Initiated 2025-02-13. Affected lots/codes: Model/Catalog Number: G5S-80C; UDI-DI: 00812394021284; Serial Numbers: D00000171086, D00000171087, D00000171088, D00000171089, D00000171090, D00000171092, D00000171093, D00000171094, D00000171095, D00000171096, D00000171097, D00000171098, D00000171099, D00000171100, D00000171101, D00000171102, D00000171103, D00000171105, D00000171107, D00000171109, D00000171111, D00000171113, D00000171115, D00000171117, D00000171118, D00000171121, D00000171126, D00000171133, D00000171134, D00000171136, D00000171138, D00000171140, D00000171144, D00000171147, D00000171150, D00000171154, D00000171157, D00000171159, D00000171160, D00000171164, D00000171165, D00000171166, D00000171167, D00000171168, D00000171169, D00000171170, D00000171171, …
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-1321-2025 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.