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  "name": "Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.",
  "description": "FDA recall Z-1143-2025 — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is recalling Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027. (Devices, Class I). 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": "FDA recall Z-1143-2025: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is recalling Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.",
      "text": "The FDA logged enforcement record Z-1143-2025: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is voluntarily recalling Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027. — reason: Possibility of the patient falling from the table related to the mattress used on the patient table.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-01-13. Affected lots/codes: Catalog numbers: (1) 722005, (2) 722011, (3) 722027; UDI-DI: (1) No UDI, (2) 00884838059047, (3) 00884838054196; Serial Numbers: (1) 361, 212, 321, 435, 285, 384, 388, 340, 343, 399, 392, 565, 355, 367, 308, 348, 271, 530, 520, 323, 510, 49, 329, 365, 269, 270, 523, 490, 357, 346, 258, 298, 316, 485, 8095, 261, 2189, 352, 474, 497, 251, 63, 456, 360, 305, 419, 405, 489, 306, 307, 429, 447, 345, 342, 272, 531, 440, 441, 416, 116, 121, 136, 58, 561, 351, 52, CV.502, 478, 8, 55, 560, 341, 403, 25, 54, 354, 385, 26, 234, 287, 459, 469, 300, 494, 72, 76, 564, 754, 125, 519, 457, 373, 430, 499, 332, 508, 374, 85, 463, 464, 428, 500, 276, 359, 487, 538, 415, 328, 397, 366, 389, 378, 379, 371, 81, 511, 473, 209, 369, 543, 394, 507, 533, 482, 495, 333, 237, 339, 338, 467, 528, 53, 401, 325, 491 ****Serial Numbers Added 5/2/2025**** 63, 308, 8095, 8, 81, 116, 121, 136, 300, 325, 345.         (2) 157, 83, 268, 308, 380, 95, 107, 34, 59, 23, 319, 49, 170, 137, 173, 101, 84, 155, 133, 234, 345, 124, 332, 102, 270, 177, 132, 325, 15, 76, 79, 17, 237, 255, 50, 171, 362, 168, 22, 275, 344, 324, 163, 375, 103, 82, 154, 215, 40, 328, 69, 374, 286, 81, 272, 293, 294, 224, 175, 117, 334, 338, 6, 146, 145, 355, 231, 323, 164, 151, 184, 266, 21, 80, 202, 165, 179, 367, 372, 203, 214, 369, 340, 18, 301, 302, 303, 304, 305, 306, 307, 318, 98, 211, 158, 271, 204, 246, 206, 321, 78, 295, 104, 217, 257, 265, 261, 253, 94, 225, 125, 38, 39, 176, 290, 291, 282, 216, 333, 329, 178, 127, 249, 230, 198, 244, 292, 180, 183, 314, 337, 201, 341, 376, 377, 378, 56, 259, 181, 317, 347, 287, 86, 300, 88, 309, 99, 233, 31, 156, 71, 222, 77, 188, 223, 238, 153, 51, 129, 68, 278, 118, 119, 186, 32, 108, 89, 258, 263, 41, 55, 310, 371, 66, 274, 139, 141, 227, 243, 296, 191, 220, 242, 166, 161, 273, 190, 189, 260, 280, 74, 75, 251, 228, 100, 199, 194, 91, 213, 212, 12, 115, 152, 111, 116, 113, 112, 114, 43, 277, 313, 26, 29 ****Serial Numbers Added 5/2/2025****  87, 124, 172, 237, 31, 36, 51, 78, 113, 151, 161, 175, 179, 181, 191, 225, 243, 291, 296, 369, 371;      (3) 203, 335, 123, 133, 134, 284, 280, 183, 106, 169, 107, 234, 42, 179, 101, 265, 306, 307, 209, 267, 153, 40, 332, 156, 112, 305, 1, 104, 231, 263, 342, 71, 255, 351, 175, 298, 120, 116, 174, 240, 241, 29, 50, 288, 56, 152, 43, 49, 202, 178, 266, 127, 319, 39, 164, 160, 27, 64, 78, 98, 245, 221, 352, 99, 55, 6, 86, 360, 7, 145, 214, 102, 204, 44, 210, 254, 84, 228, 297, 268, 77, 114, 115, 142, 30, 79, 38, 85, 189, 181, 321, 343, 144, 177, 165, 225, 211, 201, 3, 246, 291, 217, 215, 73, 315, 68, 87, 304, 51, 308, 289, 355, 21, 23, 24, 90, 171, 45, 128, 34, 122, 220, 33, 137, 287, 163, 67, 88, 232, 150, 208, 96, 310, 143, 155, 20, 166, 198, 242, 243, 269, 239, 147, 139, 180, 91, 136, 191, 197, 118, 193, 59, 312, 309, 311, 69, 296, 119, 276, 278, 250, 65, 168, 206, 158, 218, 66, 329, 75, 19, 141, 62, 330, 219, 138, 121, 264, 227, 286, 18, 31, 272, 235, 131, 195, 28, 326, 192, 207, 199, 125, 233, 148, 149, 58, 271, 212, 184, 328, 362, 5, 46, 47, 236, 135, 275, 159, 316, 277, 249, 223, 270, 322, 100, 103, 110, 57, 63, 244, 274, 256, 273, 61, 348, 349, 350, 36, 151, 300, 299, 167, 247, 282, 60, 259, 81, 126, 130, 70, 188, 347, 213, 339, 358, 94, 154, 172, 35, 346, 294, 97, 196, 76, 95, 357, 345, 361, 323, 324, 292, 293, 187, 337, 334, 338, 238, 356, 170, 146, 53, 162, 48, 205, 182, 82, 260, 261, 117, 80, 113, 186, 132 ****Serial Numbers Added 5/2/2025**** 179, 231, 63, 77, 97, 98;. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1143-2025 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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",
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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": "Possibility of the patient falling from the table related to the mattress used on the patient table.",
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            "Field": "Initiated",
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            "Value": "Catalog numbers: (1) 722005, (2) 722011, (3) 722027; UDI-DI: (1) No UDI, (2) 00884838059047, (3) 00884838054196; Serial Numbers: (1) 361, 212, 321, 435, 285, 384, 388, 340, 343, 399, 392, 565, 355, 367, 308, 348, 271, 530, 520, 323, 510, 49, 329, 365, 269, 270, 523, 490, 357, 346, 258, 298, 316, 485, 8095, 261, 2189, 352, 474, 497, 251, 63, 456, 360, 305, 419, 405, 489, 306, 307, 429, 447, 345, 342, 272, 531, 440, 441, 416, 116, 121, 136, 58, 561, 351, 52, CV.502, 478, 8, 55, 560, 341, 403, 25, 54, 354, 385, 26, 234, 287, 459, 469, 300, 494, 72, 76, 564, 754, 125, 519, 457, 373, 430, 499, 332, 508, 374, 85, 463, 464, 428, 500, 276, 359, 487, 538, 415, 328, 397, 366, 389, 378, 379, 371, 81, 511, 473, 209, 369, 543, 394, 507, 533, 482, 495, 333, 237, 339, 338, 467, 528, 53, 401, 325, 491 ****Serial Numbers Added 5/2/2025**** 63, 308, 8095, 8, 81, 116, 121, 136, 300, 325, 345.         (2) 157, 83, 268, 308, 380, 95, 107, 34, 59, 23, 319, 49, 170, 137, 173, 101, 84, 155, 133, 234, 345, 124, 332, 102, 270, 177, 132, 325, 15, 76, 79, 17, 237, 255, 50, 171, 362, 168, 22, 275, 344, 324, 163, 375, 103, 82, 154, 215, 40, 328, 69, 374, 286, 81, 272, 293, 294, 224, 175, 117, 334, 338, 6, 146, 145, 355, 231, 323, 164, 151, 184, 266, 21, 80, 202, 165, 179, 367, 372, 203, 214, 369, 340, 18, 301, 302, 303, 304, 305, 306, 307, 318, 98, 211, 158, 271, 204, 246, 206, 321, 78, 295, 104, 217, 257, 265, 261, 253, 94, 225, 125, 38, 39, 176, 290, 291, 282, 216, 333, 329, 178, 127, 249, 230, 198, 244, 292, 180, 183, 314, 337, 201, 341, 376, 377, 378, 56, 259, 181, 317, 347, 287, 86, 300, 88, 309, 99, 233, 31, 156, 71, 222, 77, 188, 223, 238, 153, 51, 129, 68, 278, 118, 119, 186, 32, 108, 89, 258, 263, 41, 55, 310, 371, 66, 274, 139, 141, 227, 243, 296, 191, 220, 242, 166, 161, 273, 190, 189, 260, 280, 74, 75, 251, 228, 100, 199, 194, 91, 213, 212, 12, 115, 152, 111, 116, 113, 112, 114, 43, 277, 313, 26, 29 ****Serial Numbers Added 5/2/2025****  87, 124, 172, 237, 31, 36, 51, 78, 113, 151, 161, 175, 179, 181, 191, 225, 243, 291, 296, 369, 371;      (3) 203, 335, 123, 133, 134, 284, 280, 183, 106, 169, 107, 234, 42, 179, 101, 265, 306, 307, 209, 267, 153, 40, 332, 156, 112, 305, 1, 104, 231, 263, 342, 71, 255, 351, 175, 298, 120, 116, 174, 240, 241, 29, 50, 288, 56, 152, 43, 49, 202, 178, 266, 127, 319, 39, 164, 160, 27, 64, 78, 98, 245, 221, 352, 99, 55, 6, 86, 360, 7, 145, 214, 102, 204, 44, 210, 254, 84, 228, 297, 268, 77, 114, 115, 142, 30, 79, 38, 85, 189, 181, 321, 343, 144, 177, 165, 225, 211, 201, 3, 246, 291, 217, 215, 73, 315, 68, 87, 304, 51, 308, 289, 355, 21, 23, 24, 90, 171, 45, 128, 34, 122, 220, 33, 137, 287, 163, 67, 88, 232, 150, 208, 96, 310, 143, 155, 20, 166, 198, 242, 243, 269, 239, 147, 139, 180, 91, 136, 191, 197, 118, 193, 59, 312, 309, 311, 69, 296, 119, 276, 278, 250, 65, 168, 206, 158, 218, 66, 329, 75, 19, 141, 62, 330, 219, 138, 121, 264, 227, 286, 18, 31, 272, 235, 131, 195, 28, 326, 192, 207, 199, 125, 233, 148, 149, 58, 271, 212, 184, 328, 362, 5, 46, 47, 236, 135, 275, 159, 316, 277, 249, 223, 270, 322, 100, 103, 110, 57, 63, 244, 274, 256, 273, 61, 348, 349, 350, 36, 151, 300, 299, 167, 247, 282, 60, 259, 81, 126, 130, 70, 188, 347, 213, 339, 358, 94, 154, 172, 35, 346, 294, 97, 196, 76, 95, 357, 345, 361, 323, 324, 292, 293, 187, 337, 334, 338, 238, 356, 170, 146, 53, 162, 48, 205, 182, 82, 260, 261, 117, 80, 113, 186, 132 ****Serial Numbers Added 5/2/2025**** 179, 231, 63, 77, 97, 98;",
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.",
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