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  "name": "ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures.  Material Number: 10848600",
  "description": "FDA recall Z-1469-2023 — Siemens Medical Solutions USA, Inc is recalling ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures.  Material Number: 10848600 (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": "ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures.  Material Number: 10848600",
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      "name": "FDA recall Z-1469-2023: Siemens Medical Solutions USA, Inc is recalling ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures.  Material Number: 10848600",
      "text": "The FDA logged enforcement record Z-1469-2023: Siemens Medical Solutions USA, Inc is voluntarily recalling ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures.  Material Number: 10848600 — reason: Examination room monitor connected with the hybrid cable may have a display issue and no image function is available. Status: Ongoing — the recall is still being carried out.. Initiated 2023-03-21. Affected lots/codes: UDI-DI: 04056869009964 US Serial Numbers:  82587 82570 82577 82562  OUS Serial Numbers; 82601 82629 82663 82695 82432 82542 82619 82631 82433 82574 82606 82610 82655 82675 82676 82700 82705 82706 82326 82327 82438 82454 82477 82484 82494 82500 82502 82506 82508 82512 82515 82516 82517 82519 82520 82525 82526 82529 82530 82531 82533 82536 82537 82539 82540 82549 82561 82568 82576 82581 82582 82585 82586 82593 82594 82599 82607 82608 82609 82616 82617 82618 82621 82622 82625 82626 82628 82639 82642 82643 82644 82646 82647 82649 82650 82651 82661 82662 82673 82685 82687 82689 82690 82693 82698 82699 82702 82703 82707 82349 82532 82546 82589 82592 82603 82634 82635 82652 82679 82548 82704 82583 82407 82555 82495 82667 82543 82666 82528 82545 82552 82668 82671 82523 82659 82565 82447 82482 82572 82638 82640 82701 82403 82467 82498 82535 82580 82678 82680 82600 82597 82237 82563 82225 82692 82567 82554 82573 82579 82553 82670. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1469-2023&lang=eng",
        "value": "Devices recall, status Ongoing",
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      "name": "FDA classified recall Z-1469-2023 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.",
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        "value": "Class II",
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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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        "adjudicator": null
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      "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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            "Field": "Reason",
            "Value": "Examination room monitor connected with the hybrid cable may have a display issue and no image function is available",
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            "Value": "UDI-DI: 04056869009964 US Serial Numbers:  82587 82570 82577 82562  OUS Serial Numbers; 82601 82629 82663 82695 82432 82542 82619 82631 82433 82574 82606 82610 82655 82675 82676 82700 82705 82706 82326 82327 82438 82454 82477 82484 82494 82500 82502 82506 82508 82512 82515 82516 82517 82519 82520 82525 82526 82529 82530 82531 82533 82536 82537 82539 82540 82549 82561 82568 82576 82581 82582 82585 82586 82593 82594 82599 82607 82608 82609 82616 82617 82618 82621 82622 82625 82626 82628 82639 82642 82643 82644 82646 82647 82649 82650 82651 82661 82662 82673 82685 82687 82689 82690 82693 82698 82699 82702 82703 82707 82349 82532 82546 82589 82592 82603 82634 82635 82652 82679 82548 82704 82583 82407 82555 82495 82667 82543 82666 82528 82545 82552 82668 82671 82523 82659 82565 82447 82482 82572 82638 82640 82701 82403 82467 82498 82535 82580 82678 82680 82600 82597 82237 82563 82225 82692 82567 82554 82573 82579 82553 82670",
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            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution in the states of FL, SD, PR and the countries of  Angola, Argentina, Australia, Brazil, Bulgaria, China, Georgia, Germany, India, Indonesia,  Iraq, Japan, Malaysia, Morocco, Nepal, Nigeria, Poland, Russia, Rwanda, Serbia, Slovenia, South Africa, Spain, Sudan, Syria, Taiwan, Thailand, Uganda, Ukraine, United Kingdom, Uzbekistan, Vietnam.",
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