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  "name": "Ingenia Ambition S  Model Number (REF):   (1) 782139;  (2) 782133;  (3) 782108;  (4) 781359",
  "description": "FDA recall Z-1850-2024 — Philips North America Llc is recalling Ingenia Ambition S  Model Number (REF):   (1) 782139;  (2) 782133;  (3) 782108;  (4) 781359 (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": "Ingenia Ambition S  Model Number (REF):   (1) 782139;  (2) 782133;  (3) 782108;  (4) 781359",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1850-2024/enforcement-record",
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      "name": "FDA recall Z-1850-2024: Philips North America Llc is recalling Ingenia Ambition S  Model Number (REF):   (1) 782139;  (2) 782133;  (3) 782108;  (4) 781359",
      "text": "The FDA logged enforcement record Z-1850-2024: Philips North America Llc is voluntarily recalling Ingenia Ambition S  Model Number (REF):   (1) 782139;  (2) 782133;  (3) 782108;  (4) 781359 — reason: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's  technical room, resulting in Smoke and/or fire. Status: Ongoing — the recall is still being carried out.. Initiated 2024-05-03. Affected lots/codes: UDI-DI:  (1) 782139 (01)00884838108639(21); (2) 782133 N/A; (3) 782108 (01)00884838098343(21); (4) 781359 (01)00884838090057(21)  Serial Numbers: Serial Number 48016 48053 48126 48003 48136 48285 48144 48020 48030 48124 48155 48191 48216 48218 48245 48300 48183 48186 48187 48222 48225 48234 48240 48241 48249 48269 48278 48284 48288 48293 48294 48299 48304 48313 48317 48326 48331 48051 48223 48207 48028 48031 48049 48050 48131 48134 48154 48160 48242 48254 48219 48000 48004 48005 48009 48019 48032 48132 48145 48224 48244 48040 48122 48039 48022 48152 48173 48012 48014 48036 48037 48044 48127 48151 48158 48174 48184 48043 48046 48047 48055 48128 48129 48153 48178 48180 48190 48192 48194 48226 48275 48181 48198 48199 48200 48023 48033 48045 48001 48038 48167 48185 48196 48236 48238 48239 48034 48276 48010 48170 48035 48172 48027 48248 48146 48147 48148 48163 48164 48165 48169 48182 48188 48271 48291 48297 48302 48303 48308 48309 48310 48329 48018 48283 48177 48011 48017 48056 48250 48272 48253 48268 48013 48015 48052 48112 48120 48130 48162 48166 48171 48179 48214 48217 48233 48237 48243 48252 48273 48274 48286 48287 48314 48026 48322 48133 48316 48558 48572 48566 48581 48592 48652 48800 48893 48544 48506 48520 48521 48534 48551 48712 48714 48715 48810 48813 48833 48883 48885 48538 48539 48602 48613 48650 48501 48502 48507 48514 48530 48540 48568 48569 48577 48579 48580 48590 48591 48614 48620 48629 48632 48638 48641 48503 48606 48660 48529 48609 48622 48541 48549 48616 48504 48508 48513 48524 48536 48537 48555 48560 48571 48573 48585 48593 48594 48597 48600 48522 48561 48564 48668 48726 48519 48532 48533 48505 48510 48567 48604 48515 48584 48512 48582 48647 48850 48610 48615 48500 48523 48535 48546 48552 48554 48562 48575 48578 48586 48637 48645 48648 48656 48525 48526 27500 27502 27504 27505 27506 27507 27508 27509 27511 27512 27514 27515 27516 27517 27518 27519 27520 27522 27523 27524 27525 27526 27527 27528 27529 27530 27531 27532 27533 27535 27536 27539 27541 27542 27543 27544 29021 29000 29010 29011 29012 29014 29017 29018 29025 29003 29006 29009 29015 29023 29013 29027 29005 29019. 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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1850-2024/fda-classification",
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      "name": "FDA classified recall Z-1850-2024 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.",
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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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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1850-2024/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.",
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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "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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      "name": "FDA recall details — Z-1850-2024",
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            "Field": "Reason",
            "Value": "The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's  technical room, resulting in Smoke and/or fire",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2024-05-03",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "UDI-DI:  (1) 782139 (01)00884838108639(21); (2) 782133 N/A; (3) 782108 (01)00884838098343(21); (4) 781359 (01)00884838090057(21)  Serial Numbers: Serial Number 48016 48053 48126 48003 48136 48285 48144 48020 48030 48124 48155 48191 48216 48218 48245 48300 48183 48186 48187 48222 48225 48234 48240 48241 48249 48269 48278 48284 48288 48293 48294 48299 48304 48313 48317 48326 48331 48051 48223 48207 48028 48031 48049 48050 48131 48134 48154 48160 48242 48254 48219 48000 48004 48005 48009 48019 48032 48132 48145 48224 48244 48040 48122 48039 48022 48152 48173 48012 48014 48036 48037 48044 48127 48151 48158 48174 48184 48043 48046 48047 48055 48128 48129 48153 48178 48180 48190 48192 48194 48226 48275 48181 48198 48199 48200 48023 48033 48045 48001 48038 48167 48185 48196 48236 48238 48239 48034 48276 48010 48170 48035 48172 48027 48248 48146 48147 48148 48163 48164 48165 48169 48182 48188 48271 48291 48297 48302 48303 48308 48309 48310 48329 48018 48283 48177 48011 48017 48056 48250 48272 48253 48268 48013 48015 48052 48112 48120 48130 48162 48166 48171 48179 48214 48217 48233 48237 48243 48252 48273 48274 48286 48287 48314 48026 48322 48133 48316 48558 48572 48566 48581 48592 48652 48800 48893 48544 48506 48520 48521 48534 48551 48712 48714 48715 48810 48813 48833 48883 48885 48538 48539 48602 48613 48650 48501 48502 48507 48514 48530 48540 48568 48569 48577 48579 48580 48590 48591 48614 48620 48629 48632 48638 48641 48503 48606 48660 48529 48609 48622 48541 48549 48616 48504 48508 48513 48524 48536 48537 48555 48560 48571 48573 48585 48593 48594 48597 48600 48522 48561 48564 48668 48726 48519 48532 48533 48505 48510 48567 48604 48515 48584 48512 48582 48647 48850 48610 48615 48500 48523 48535 48546 48552 48554 48562 48575 48578 48586 48637 48645 48648 48656 48525 48526 27500 27502 27504 27505 27506 27507 27508 27509 27511 27512 27514 27515 27516 27517 27518 27519 27520 27522 27523 27524 27525 27526 27527 27528 27529 27530 27531 27532 27533 27535 27536 27539 27541 27542 27543 27544 29021 29000 29010 29011 29012 29014 29017 29018 29025 29003 29006 29009 29015 29023 29013 29027 29005 29019",
            "Status": "recorded"
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            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada,  China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan,  Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia,  Spain, Sweden, Switzerland, Thailand, United Kingdom.",
            "Status": "recorded"
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