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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2525-2024.jsonld",
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  "name": "Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image.  Model Number: 10762472",
  "description": "FDA recall Z-2525-2024 — Siemens Medical Solutions USA, Inc is recalling Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image.  Model Number: 10762472 (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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2525-2024/enforcement-record",
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      "name": "FDA recall Z-2525-2024: Siemens Medical Solutions USA, Inc is recalling Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image.  Model Number: 10762472",
      "text": "The FDA logged enforcement record Z-2525-2024: Siemens Medical Solutions USA, Inc is voluntarily recalling Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image.  Model Number: 10762472 — reason: The support arm may unintentionally lower resulting in injury to persons when they are under the  display ceiling/wall suspension when positioning the displays. Status: Ongoing — the recall is still being carried out.. Initiated 2024-07-02. Affected lots/codes: UDI: (01)04056869009162(21) Serial Numbers; Serial Number 64144 61058 64374 64413 64433 64048 64460 64385 64036 64013 64448 64451 64445 64057 64205 64326 64055 64051 64262 64288 64338 64061 64131 64314 64399 64034 64443 64105 64019 64309 64325 61231 64032 64170 64088 64457 64478 64104 64244 64449 64316 64111 64280 64239 64241 64420 64412 64136 64273 64112 64247 64329 64124 64486 64196 64320 64388 64147 64446 64479 64290 64299 64397 64228 64117 64176 64327 64251 64098 64060 64441 64452 64100 64313 64082 64041 64035 64029 64110 64381 63388 64278 64444 64078 64191 64435 64331 64174 64377 64426 64300 64118 64333 64127 64257 64348 64281 64211 64382 64271 64149 64346 64464 64266 64199 64431 64179 64336 64396 64099 64090 64107 64172 64469 64180 64364 63386 64384 64238 64305 64484 64311 64221 64285 64204 64265 64408 64383 64154 64103 64483 64407 64470 64248 64021 64418 64334 64276 64252 64400 64120 64083 64150 64129 64053 64089 64058 64145 64141 64073 64347 64332 64471 64185 64193 64390 64393 64079 64222 64437 64246 64065 64328 64303 64080 64062 64069 64227 64242 64139 64152 64220 64143 64360 64292 64163 64337 64411 64160 63382 64054 64272 64064 64462 64417 64282 64343 64068 64259 64330 64355 64215 64256 64156 64439 64175 64293 64323 64250 64286 64212 64480 64409 64318 64047 64243 64267 64224 64071 64031 64380 64218 64352 64466 64130 64315 64161 64162 64184 64093 64277 64270 64481 64477 64166 64072 64043 64226 64183 64294 64126 64361 64306 64304 64158 64291 64322 64474 64386 64468 64368 64018 64223 64376 64342 64353 64317 64312 64027 64232 64066 64091 64363 64350 64076 64074 64356 64268 64458 64307 64039 63372 64203 64159 64146 64208 64210 64467 64135 64165 64392 64229 64324 64123 64022 64432 64157 64394 64406 64447 64345 64344 64490 64216 64308 64372 64373 64173 64164 64463 64351 64358 64391 64234 64283 64440 64087 64121 64012 64178 64370 64403 64028 64209 64040 64190 64405 64067 64438 64045 64202 64485 64410 64155 64371 64097 64070 64416 64125 64455 64182 64133 64428 64171 64302 64106 64387 64422 64354 64049 64015 64434 64454. 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-2525-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2525-2024 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-2525-2024/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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        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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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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            "Value": "The support arm may unintentionally lower resulting in injury to persons when they are under the  display ceiling/wall suspension when positioning the displays",
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            "Value": "UDI: (01)04056869009162(21) Serial Numbers; Serial Number 64144 61058 64374 64413 64433 64048 64460 64385 64036 64013 64448 64451 64445 64057 64205 64326 64055 64051 64262 64288 64338 64061 64131 64314 64399 64034 64443 64105 64019 64309 64325 61231 64032 64170 64088 64457 64478 64104 64244 64449 64316 64111 64280 64239 64241 64420 64412 64136 64273 64112 64247 64329 64124 64486 64196 64320 64388 64147 64446 64479 64290 64299 64397 64228 64117 64176 64327 64251 64098 64060 64441 64452 64100 64313 64082 64041 64035 64029 64110 64381 63388 64278 64444 64078 64191 64435 64331 64174 64377 64426 64300 64118 64333 64127 64257 64348 64281 64211 64382 64271 64149 64346 64464 64266 64199 64431 64179 64336 64396 64099 64090 64107 64172 64469 64180 64364 63386 64384 64238 64305 64484 64311 64221 64285 64204 64265 64408 64383 64154 64103 64483 64407 64470 64248 64021 64418 64334 64276 64252 64400 64120 64083 64150 64129 64053 64089 64058 64145 64141 64073 64347 64332 64471 64185 64193 64390 64393 64079 64222 64437 64246 64065 64328 64303 64080 64062 64069 64227 64242 64139 64152 64220 64143 64360 64292 64163 64337 64411 64160 63382 64054 64272 64064 64462 64417 64282 64343 64068 64259 64330 64355 64215 64256 64156 64439 64175 64293 64323 64250 64286 64212 64480 64409 64318 64047 64243 64267 64224 64071 64031 64380 64218 64352 64466 64130 64315 64161 64162 64184 64093 64277 64270 64481 64477 64166 64072 64043 64226 64183 64294 64126 64361 64306 64304 64158 64291 64322 64474 64386 64468 64368 64018 64223 64376 64342 64353 64317 64312 64027 64232 64066 64091 64363 64350 64076 64074 64356 64268 64458 64307 64039 63372 64203 64159 64146 64208 64210 64467 64135 64165 64392 64229 64324 64123 64022 64432 64157 64394 64406 64447 64345 64344 64490 64216 64308 64372 64373 64173 64164 64463 64351 64358 64391 64234 64283 64440 64087 64121 64012 64178 64370 64403 64028 64209 64040 64190 64405 64067 64438 64045 64202 64485 64410 64155 64371 64097 64070 64416 64125 64455 64182 64133 64428 64171 64302 64106 64387 64422 64354 64049 64015 64434 64454",
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