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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0138-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System",
  "description": "FDA recall Z-0138-2024 — GE Healthcare is recalling Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System (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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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0138-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System",
    "manufacturer": {
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      "name": "GE Healthcare"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0138-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0138-2024: GE Healthcare is recalling Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System",
      "text": "The FDA logged enforcement record Z-0138-2024: GE Healthcare is voluntarily recalling Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System — reason: GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-09-14. Affected lots/codes: UDI/DI none, Installed Product ID #:  101792-1-Centricity PACS-IW-00558370, 4345-1-Centricity PACS-IW-00558548, 12830-1-Centricity PACS-IW-00558312, 4378-1-Centricity PACS-IW-00558498, 100663-1-Centricity PACS-IW-00558514, 100858-1-Centricity PACS-IW-00558426, 100702-1-Centricity PACS-IW-00558539, 4109-1-Centricity PACS-IW-00558389, 101625-1-Centricity PACS-IW-00558531, 4593-1-Centricity PACS-IW-00558488, 100009-1-Centricity PACS-IW-00558560, 100838-1-Centricity PACS-IW-00558532, 4300-1-Centricity PACS-IW-00558207, 4294-1-Centricity PACS-IW-00558379, 13039-1-Centricity PACS-IW-00558385, 13102-1-Centricity PACS-IW-00558512, 4694-1-Centricity PACS-IW-00558556, 101742-1-Centricity PACS-IW-00558470, 101883-1-Centricity PACS-IW-00558487, 9791-1-Centricity PACS-IW-00558418, 11764-1-Centricity PACS-IW-00558388, 101689-1-Centricity PACS-IW-00558326, 4744-1-Centricity PACS-IW-00558373, 4358-1-Centricity PACS-IW-00558564, 1402-7-Centricity PACS-IW-18957305, 1402-7-Centricity PACS-IW-19265438, 1402-7-Centricity PACS-IW-18166109, 1402-7-Centricity PACS-IW-18166110, 1402-2-Centricity PACS-IW-18984905, 1402-2-Centricity PACS-IW-18985934, 1402-2-Centricity PACS-IW-19031647, 1402-1-Centricity PACS-IW-17192703, 1402-1-Centricity PACS-IW-17192704, 1402-1-Centricity PACS-IW-00558291, 13095-1-Centricity PACS-IW-00558534, 4326-4-Centricity PACS-IW-00558105, 4352-1-Centricity PACS-IW-00558316, 4443-1-Centricity PACS-IW-00558167, 4374-1-Centricity PACS-IW-00558422, 4301-1-Centricity PACS-IW-00558525, 2387-1-Centricity PACS-IW-00558489, 4277-1-Centricity PACS-IW-00558474, 100802-1-Centricity PACS-IW-00558540, 101216-1-Centricity PACS-IW-00558356, 101193-1-Centricity PACS-IW-00558551, 101240-1-Centricity PACS-IW-00558425, 4661-1-Centricity PACS-IW-00558528, 3943-1-Centricity PACS-IW-00558501, 4361-1-Centricity PACS-IW-00558343, 12949-1-Centricity PACS-IW-00558442, 4276-1-Centricity PACS-IW-00558274, 4383-1-Centricity PACS-IW-00558533, 13233-3-Centricity PACS-IW-00558554, 12974-1-Centricity PACS-IW-00558300, 4393-1-Centricity PACS-IW-00558328, 4482-1-Centricity PACS-IW-00558281, 4389-1-Centricity PACS-IW-00558563, 100645-1-Centricity PACS-IW-14764451, 4573-1-Centricity PACS-IW-00558420, 4506-1-Centricity PACS-IW-00558345, AZ4030-Centricity PACS-IW-02336621, BA4080-Centricity PACS-IW-00038769, 707509-Centricity PACS-IW-01452391, 324462-Centricity PACS-IW-01431554, 613493-Centricity PACS-IW-02292544, 302144-Centricity PACS-IW-01421157, 246838-Centricity PACS-IW-01421153, 213537-Centricity PACS-IW-01431510, 319674-Centricity PACS-IW-01431535, 280801-Centricity PACS-IW-01431490, 320090-Centricity PACS-IW-01444604, 307319-Centricity PACS-IW-01444609, SiteID-Centricity PACS-IW-01572187, RMUE01-Centricity PACS-IW-00001801, StThomas-Centricity PACS-IW-01819447, HOLY-FAMILY-THODU-Centricity PACS-IW-01821493, WOCKHARDT-Centricity PACS-IW-01819449, SIMS-Centricity PACS-IW-01819453, MARTHANDAM-Centricity PACS-IW-01819446, CONTINENTAL-Centricity PACS-IW-01819443, A2513980-Centricity PACS-IW-00040355, KW1019-Centricity PACS-IW-00115173, KW1112-Centricity PACS-IW-00168151, KW1018-Centricity PACS-IW-01422962, KW1003-Centricity PACS-IW-01798078, KW1001-Centricity PACS-IW-00164288, SSH-Centricity PACS-IW-01288660, PL2997-Centricity PACS-IW-00038793, PL1803-Centricity PACS-IW-00038812, PL1825-Centricity PACS-IW-00038819, PL1006-Centricity PACS-IW-00038821, PL1822-Centricity PACS-IW-00038825, TBD-Centricity PACS-IW-01273193, RU1241-Centricity PACS-IW-01273216, RU1493-Centricity PACS-IW-01273220, TBD-Centricity PACS-IW-01273244, RU2420-Centricity PACS-IW-01273234, RU3262-Centricity PACS-IW-01273245, RU6248-Centricity PACS-IW-01273279, RU8052-Centricity PACS-IW-02337508, RU8071-Centricity PACS-IW-01273295, -Centricity PACS-IW-01273233, RU7576-Centricity PACS-IW-01273287, RU3880-Centricity PACS-IW-01273266, RU2580-Centricity PACS-IW-01273240, RU2527-Centricity PACS-IW-01273235, RU3382-Centricity PACS-IW-01273247, RU2878-Centricity PACS-IW-01273243, TBD-Centricity PACS-IW-01273306, TBD-Centricity PACS-IW-01273258, RU5499-Centricity PACS-IW-01273278, RU3680-Centricity PACS-IW-01273260, RU1279-Centricity PACS-IW-02337628, RU1469-Centricity PACS-IW-01273219, TBD-Centricity PACS-IW-01273200, RU8321-Centricity PACS-IW-01273303, RU1130-Centricity PACS-IW-01273210, RU7426-Centricity PACS-IW-01273284, RU3380-Centricity PACS-IW-01273246, TBD-Centricity PACS-IW-01273262, TBD-Centricity PACS-IW-01273224, RU8953-Centricity PACS-IW-01273311, RU2367-Centricity PACS-IW-01273232, RU1026-Centricity PACS-IW-01273195, TBD-Centricity PACS-IW-01273198, RU8036-Centricity PACS-IW-01273293, RU7564-Centricity PACS-IW-01273286, RU3476-Centricity PACS-IW-01273251, RU3610-Centricity PACS-IW-01273257, RU1028-Centricity PACS-IW-01273197, RU1022-Centricity PACS-IW-01273194, RU5442-Centricity PACS-IW-01273277, RU3883-Centricity PACS-IW-01273267, RU3467-Centricity PACS-IW-01273250, RU3663-Centricity PACS-IW-01273259, RU7905-Centricity PACS-IW-01273291, TBD-Centricity PACS-IW-01273256, TBD-Centricity PACS-IW-01273296, RU7838-Centricity PACS-01273289, TBD-Centricity PACS-IW-01273218, RU8607-Centricity PACS-IW-01273308, ZA2470-Centricity PACS-IW-00116572, ZA2352-Centricity PACS-IW-00116570, ZA2471-Centricity PACS-IW-00116573, ZA2351-Centricity PACS-IW-00116569, ZA2356-Centricity PACS-IW-00116576, ZA2355-Centricity PACS-IW-00116575, 14335625-Centricity PACS-IW-20614918, ONCOLOGY-Centricity PACS-IW-01288658. A RECORDED FDA enforcement action (occurred=true).",
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        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0138-2024&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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      "name": "FDA classified recall Z-0138-2024 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": {
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        "adjudged": true,
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0138-2024&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0138-2024&lang=eng"
        }
      },
      "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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0138-2024/boundary",
      "@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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        "supported": true,
        "adjudged": false,
        "operative": true
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      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "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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  "hasPart": [
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      "name": "FDA recall details — Z-0138-2024",
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            "Value": "Z-0138-2024",
            "Status": "recorded"
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          "item": {
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            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "position": 4,
          "item": {
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "GE Healthcare",
            "Status": "recorded"
          }
        },
        {
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.",
            "Status": "recorded"
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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-09-14",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "UDI/DI none, Installed Product ID #:  101792-1-Centricity PACS-IW-00558370, 4345-1-Centricity PACS-IW-00558548, 12830-1-Centricity PACS-IW-00558312, 4378-1-Centricity PACS-IW-00558498, 100663-1-Centricity PACS-IW-00558514, 100858-1-Centricity PACS-IW-00558426, 100702-1-Centricity PACS-IW-00558539, 4109-1-Centricity PACS-IW-00558389, 101625-1-Centricity PACS-IW-00558531, 4593-1-Centricity PACS-IW-00558488, 100009-1-Centricity PACS-IW-00558560, 100838-1-Centricity PACS-IW-00558532, 4300-1-Centricity PACS-IW-00558207, 4294-1-Centricity PACS-IW-00558379, 13039-1-Centricity PACS-IW-00558385, 13102-1-Centricity PACS-IW-00558512, 4694-1-Centricity PACS-IW-00558556, 101742-1-Centricity PACS-IW-00558470, 101883-1-Centricity PACS-IW-00558487, 9791-1-Centricity PACS-IW-00558418, 11764-1-Centricity PACS-IW-00558388, 101689-1-Centricity PACS-IW-00558326, 4744-1-Centricity PACS-IW-00558373, 4358-1-Centricity PACS-IW-00558564, 1402-7-Centricity PACS-IW-18957305, 1402-7-Centricity PACS-IW-19265438, 1402-7-Centricity PACS-IW-18166109, 1402-7-Centricity PACS-IW-18166110, 1402-2-Centricity PACS-IW-18984905, 1402-2-Centricity PACS-IW-18985934, 1402-2-Centricity PACS-IW-19031647, 1402-1-Centricity PACS-IW-17192703, 1402-1-Centricity PACS-IW-17192704, 1402-1-Centricity PACS-IW-00558291, 13095-1-Centricity PACS-IW-00558534, 4326-4-Centricity PACS-IW-00558105, 4352-1-Centricity PACS-IW-00558316, 4443-1-Centricity PACS-IW-00558167, 4374-1-Centricity PACS-IW-00558422, 4301-1-Centricity PACS-IW-00558525, 2387-1-Centricity PACS-IW-00558489, 4277-1-Centricity PACS-IW-00558474, 100802-1-Centricity PACS-IW-00558540, 101216-1-Centricity PACS-IW-00558356, 101193-1-Centricity PACS-IW-00558551, 101240-1-Centricity PACS-IW-00558425, 4661-1-Centricity PACS-IW-00558528, 3943-1-Centricity PACS-IW-00558501, 4361-1-Centricity PACS-IW-00558343, 12949-1-Centricity PACS-IW-00558442, 4276-1-Centricity PACS-IW-00558274, 4383-1-Centricity PACS-IW-00558533, 13233-3-Centricity 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            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US and Austria, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, Chile, Colombia, France, Germany, India, Ireland, Italy, Kuwait, Malaysia, Netherlands, Netherlands Antilles, Panama, Poland, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, United Kingdom, Uruguay, Venezuela, Vietnam",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}