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  "name": "Azurion 7 M20.  X-ray Image guided Therapy System.",
  "description": "FDA recall Z-2284-2023 — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is recalling Azurion 7 M20.  X-ray Image guided Therapy 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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    "name": "Azurion 7 M20.  X-ray Image guided Therapy System.",
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      "name": "FDA recall Z-2284-2023: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is recalling Azurion 7 M20.  X-ray Image guided Therapy System.",
      "text": "The FDA logged enforcement record Z-2284-2023: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is voluntarily recalling Azurion 7 M20.  X-ray Image guided Therapy System. — reason: The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-06-12. Affected lots/codes: Model No.: 722079, 722224; UDI-DI: (01)00884838085268(21), (01)00884838099258(21); System Equipment Number: 69991047, 69991048, 71927518, 71929379, 71929381, 71929386, 71934809, 71935340, 71937626, 71939045, 71957323, 72045694, 72150041, 72173543, 72273457, 72312081, 72321356, 72327897, 72400707, 72414989, 72419144, 72426402, 72648857, 72719305, 72719820, 72721959, 72748229, 72771284, 72805530, 72933546, 73000862, 73003437, 73011242, 73051857, 73337310, 73337321, 73339454, 73340554, 73407813, 73461447, 73516696, 73581917, 73581968, 73616732, 73625357, 73633104, 73717291, 73861967, 74017556, 74020682, 74095702, 74154690, 74154691, 74155276, 74169049, 74227230, 74227231, 74238084, 74250404, 74288937, 74298715, 74369399, 74465159, 74517090, 74582619, 74592051, 74593412, 74608935, 74609935, 74610486, 74610632, 74611953, 74613538, 74620302, 74620341, 74697609, 74817549, 74879566, 74896878, 75215416, 75387595, 75390578, 75434973, 75551701, 75581576, 75610667, 75635433, 75714884, 75844170, 75852749, 75855479, 75935287, 76078970, 76091821, 76138290, 76417103, 76479323, 76515054, 76553358, 76577152, 76787680, 76891085, 77121963, 77427180, 77530081, 77654726, 77654982, 77777427, 77779946, 77970791, 77970948, 77992050, 78105115, 78248928, 78294148, 78301055, 78397953, 78566369, 78742461, 78871714, 78951530, 79075848, 79092310, 79109133, 79112403, 79170704, 79221166, 79260136, 79386139, 79721725, 79755150, 79871193, 80031529, 80162299, 80389257, 80518631, 80634403, 80757669, 80864517, 80909985, 81158245, 81198118, 81435812, 81576136, 81585676, 82061620, 82084127, 83171264, 83616043, 84187167, 84817818, 86188742, 86497093, 86714680, 86796686, 87030322, 87184700, 87490196, 88006565, 88182534, 88520522, 88806300, 89171879, 89418260, 91702038, 92145971, 92904015, 93089744, 93184693, 93338682, 93496319, 93571818, 93617781, 93640291, 94453083, 94693032, 95022475, 95133121, 95182889, 95492390, 95747223, 95747224, 96447199, 96449972, 97171402, 97171408, 97385374, 97640203, 98542276, 98862191, 99584876,. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-2284-2023 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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      "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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      "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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