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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2019-2025.jsonld",
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  "name": "ARTIS is a family of dedicated angiography systems developed for single and  biplane diagnostic imaging and interventional procedures including, but not  limited to, pediatric and obese patients. Procedures that can be performed  with the ARTIS family include cardiac angiography, neuro-angiography, general  angiography, rotational angiography, multipurpose angiography and whole  body radiographic/fluoroscopic procedures as well as procedures next to the  table for i.e., patient extremities. This does not include projection radiography.  Additional procedures that can be performed include angiography in the  operating room, image guided surgery by X-ray, by image fusion, and by  navigation systems. The examination table as an integrated part of the system  can be used for X-ray imaging, surgery and interventions. ARTIS can also  support the acquisition of position triggered imaging for spatial data synthesis.",
  "description": "FDA recall Z-2019-2025 — Siemens Medical Solutions USA, Inc is recalling ARTIS is a family of dedicated angiography systems developed for single and  biplane diagnostic imaging and interventional procedures including, but not  limited to, pediatric and obese patients. Procedures that can be performed  with the ARTIS family include cardiac angiography, neuro-angiography, general  angiography, rotational angiography, multipurpose angiography and whole  body radiographic/fluoroscopic procedures as well as procedures next to the  table for i.e., patient extremities. This does not include projection radiography.  Additional procedures that can be performed include angiography in the  operating room, image guided surgery by X-ray, by image fusion, and by  navigation systems. The examination table as an integrated part of the system  can be used for X-ray imaging, surgery and interventions. ARTIS can also  support the acquisition of position triggered imaging for spatial data synthesis. (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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    "@type": "schema:MedicalDevice",
    "name": "ARTIS is a family of dedicated angiography systems developed for single and  biplane diagnostic imaging and interventional procedures including, but not  limited to, pediatric and obese patients. Procedures that can be performed  with the ARTIS family include cardiac angiography, neuro-angiography, general  angiography, rotational angiography, multipurpose angiography and whole  body radiographic/fluoroscopic procedures as well as procedures next to the  table for i.e., patient extremities. This does not include projection radiography.  Additional procedures that can be performed include angiography in the  operating room, image guided surgery by X-ray, by image fusion, and by  navigation systems. The examination table as an integrated part of the system  can be used for X-ray imaging, surgery and interventions. ARTIS can also  support the acquisition of position triggered imaging for spatial data synthesis.",
    "manufacturer": {
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      "name": "Siemens Medical Solutions USA, Inc"
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      "name": "FDA recall Z-2019-2025: Siemens Medical Solutions USA, Inc is recalling ARTIS is a family of dedicated angiography systems developed for single and  biplane diagnostic imaging and interventional procedures including, but not  limited to, pediatric and obese patients. Procedures that can be performed  with the ARTIS family include cardiac angiography, neuro-angiography, general  angiography, rotational angiography, multipurpose angiography and whole  body radiographic/fluoroscopic procedures as well as procedures next to the  table for i.e., patient extremities. This does not include projection radiography.  Additional procedures that can be performed include angiography in the  operating room, image guided surgery by X-ray, by image fusion, and by  navigation systems. The examination table as an integrated part of the system  can be used for X-ray imaging, surgery and interventions. ARTIS can also  support the acquisition of position triggered imaging for spatial data synthesis.",
      "text": "The FDA logged enforcement record Z-2019-2025: Siemens Medical Solutions USA, Inc is recalling (FDA-mandated) ARTIS is a family of dedicated angiography systems developed for single and  biplane diagnostic imaging and interventional procedures including, but not  limited to, pediatric and obese patients. Procedures that can be performed  with the ARTIS family include cardiac angiography, neuro-angiography, general  angiography, rotational angiography, multipurpose angiography and whole  body radiographic/fluoroscopic procedures as well as procedures next to the  table for i.e., patient extremities. This does not include projection radiography.  Additional procedures that can be performed include angiography in the  operating room, image guided surgery by X-ray, by image fusion, and by  navigation systems. The examination table as an integrated part of the system  can be used for X-ray imaging, surgery and interventions. ARTIS can also  support the acquisition of position triggered imaging for spatial data synthesis. — reason: In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-05-15. Affected lots/codes: 4056869046877. A RECORDED FDA enforcement action (occurred=true).",
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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-2019-2025 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.",
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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.",
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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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