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  "name": "Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569,  used with CardioLab AltiX and ComboLab AltiX.",
  "description": "FDA recall Z-2613-2023 — GE Medical Systems Information Technologies Inc is recalling Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569,  used with CardioLab AltiX and ComboLab AltiX. (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.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
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      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2613-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569,  used with CardioLab AltiX and ComboLab AltiX.",
    "manufacturer": {
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      "name": "GE Medical Systems Information Technologies Inc"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2613-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2613-2023: GE Medical Systems Information Technologies Inc is recalling Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569,  used with CardioLab AltiX and ComboLab AltiX.",
      "text": "The FDA logged enforcement record Z-2613-2023: GE Medical Systems Information Technologies Inc is voluntarily recalling Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569,  used with CardioLab AltiX and ComboLab AltiX. — reason: A diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could reach elevated temperatures and fail, then power off and become inoperable.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-08-08. Affected lots/codes: GTIN 00195278507044 (CardioLab) and 00195278507051 (ComboLab)  Serial numbers for Amplifiers:  SVS22330007SA, SVS22330008SA, SVS22330009SA, SVS22330010SA, SVS22330011SA, SVS22330012SA, SVS22330013SA, SVS22330014SA, SVS22330016SA, SVS22330017SA, SVS22330018SA, SVS22330019SA, SVS22330020SA, SVS22330021SA, SVS22330022SA, SVS22330023SA, SVS22330024SA, SVS22330025SA, SVS22330026SA, SVS22330028SA, SVS22330030SA, SVS22330031SA, SVS22330032SA, SVS22330033SA, SVS22330034SA, SVS22330035SA, SVS22440001SA, SVS22440002SA, SVS22440005SA, SVS22440008SA, SVS22440009SA, SVS22440010SA, SVS22440011SA, SVS22440012SA, SVS22440013SA, SVS22440016SA, SVS22490002SA, SVS22490003SA, SVS22490004SA, SVS22520006SA, SVS22520008SA, SVS22520009SA, SVS22520010SA, SVS22520011SA, SVS22520012SA, SVS22520013SA, SVS22520015SA, SVS23040001SA, SVS23040002SA, SVS23040003SA, SVS23040004SA, SVS23040005SA, SVS23040007SA, SVS23040008SA, SVS23040011SA, SVS23040012SA, SVS23040013SA, SVS23040014SA, SVS23040015SA, SVS23040016SA, SVS23040017SA, SVS23040018SA, SVS23040019SA, SVS23070002SA, SVS23070004SA, SVS23070005SA, SVS23070008SA, SVS23070009SA, SVS23070011SA, SVS23070012SA, SVS23100001SA, SVS23100002SA, SVS23100004SA, and  SVS23100006SA.  Serial numbers for FRUs:  SVS22330015SA, SVS22440006SA, SVS22440007SA, SVS22440015SA, SVS22490001SA, SVS22520005SA, and SVS22520014SA.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2613-2023&lang=eng",
        "value": "Devices recall, status Ongoing",
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      "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."
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2613-2023/fda-classification",
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      "name": "FDA classified recall Z-2613-2023 as Class II",
      "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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
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        }
      },
      "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."
    },
    {
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      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "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.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "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."
    }
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      "name": "FDA recall details — Z-2613-2023",
      "numberOfItems": 9,
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          "item": {
            "Field": "Recall number",
            "Value": "Z-2613-2023",
            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "GE Medical Systems Information Technologies Inc",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "A diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could reach elevated temperatures and fail, then power off and become inoperable.",
            "Status": "recorded"
          }
        },
        {
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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-08-08",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "GTIN 00195278507044 (CardioLab) and 00195278507051 (ComboLab)  Serial numbers for Amplifiers:  SVS22330007SA, SVS22330008SA, SVS22330009SA, SVS22330010SA, SVS22330011SA, SVS22330012SA, SVS22330013SA, SVS22330014SA, SVS22330016SA, SVS22330017SA, SVS22330018SA, SVS22330019SA, SVS22330020SA, SVS22330021SA, SVS22330022SA, SVS22330023SA, SVS22330024SA, SVS22330025SA, SVS22330026SA, SVS22330028SA, SVS22330030SA, SVS22330031SA, SVS22330032SA, SVS22330033SA, SVS22330034SA, SVS22330035SA, SVS22440001SA, SVS22440002SA, SVS22440005SA, SVS22440008SA, SVS22440009SA, SVS22440010SA, SVS22440011SA, SVS22440012SA, SVS22440013SA, SVS22440016SA, SVS22490002SA, SVS22490003SA, SVS22490004SA, SVS22520006SA, SVS22520008SA, SVS22520009SA, SVS22520010SA, SVS22520011SA, SVS22520012SA, SVS22520013SA, SVS22520015SA, SVS23040001SA, SVS23040002SA, SVS23040003SA, SVS23040004SA, SVS23040005SA, SVS23040007SA, SVS23040008SA, SVS23040011SA, SVS23040012SA, SVS23040013SA, SVS23040014SA, SVS23040015SA, SVS23040016SA, SVS23040017SA, SVS23040018SA, SVS23040019SA, SVS23070002SA, SVS23070004SA, SVS23070005SA, SVS23070008SA, SVS23070009SA, SVS23070011SA, SVS23070012SA, SVS23100001SA, SVS23100002SA, SVS23100004SA, and  SVS23100006SA.  Serial numbers for FRUs:  SVS22330015SA, SVS22440006SA, SVS22440007SA, SVS22440015SA, SVS22490001SA, SVS22520005SA, and SVS22520014SA.",
            "Status": "recorded"
          }
        },
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Distribution was made to CA, CO, FL, GA, IL, IN, KY, MA, NC, NJ, OH, OR, PA, SC, TX, VA, and WI.  There was government distribution but no military distribution.  Foreign distribution was made to Canada, France, Germany, Greece, Ireland, Japan, Republic of Korea, and Romania.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}