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  "name": "MR 5300-  Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.  Model Number (REF):    (1) 782152   (2) 782110",
  "description": "FDA recall Z-1854-2024 — Philips North America Llc is recalling MR 5300-  Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.  Model Number (REF):    (1) 782152   (2) 782110 (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": "MR 5300-  Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.  Model Number (REF):    (1) 782152   (2) 782110",
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      "name": "FDA recall Z-1854-2024: Philips North America Llc is recalling MR 5300-  Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.  Model Number (REF):    (1) 782152   (2) 782110",
      "text": "The FDA logged enforcement record Z-1854-2024: Philips North America Llc is voluntarily recalling MR 5300-  Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.  Model Number (REF):    (1) 782152   (2) 782110 — 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) 782152 N/A (2) 782110 (01)00884838099364(21)  Serial Numbers:  79113 79118 79127 79157 79122 79147 79105 79150 79152 79183 79192 79102 79108 79112 79115 79116 79153 79156 79162 79163 79164 79168 79188 79189 79100 79126 79179 79143 79159 79104 79132 79160 79182 79165 79107 79158 79175 79136 79138 79139 79184 79176 79180 79171 79172 79111 79125 79134 79135 79148 79177 79181 79173 79187 79190 79133 79110 79101 79117 79166 79124 79123 79130 79174 79178 79151 79114 79103 79106 79121 79128 79129 79137 79140 79155 79161 79167 79169 79170 79185    Serial Number:  30199 30200 30201 30062 30191 30240 30241 30242 30305 30315 30125 30088 30113 30222 30252 30268 30028 30038 30058 30069 30081 30095 30100 30117 30118 30138 30164 30167 30168 30169 30170 30192 30197 30207 30209 30217 30228 30246 30248 30249 30256 30262 30267 30281 30284 30289 30297 30298 30306 30307 30312 30314 30210 30219 30245 30254 30276 30029 30043 30052 30061 30083 30101 30107 30114 30115 30116 30119 30120 30122 30130 30137 30140 30153 30154 30158 30159 30160 30163 30173 30174 30177 30178 30179 30196 30203 30251 30253 30259 30265 30266 30277 30279 30280 30282 30285 30291 30293 30104 30105 30216 30244 30290 30308 30316 30070 30208 30102 30112 30133 30206 30214 30224 30238 30261 30264 30274 30295 30303 30051 30084 30149 30215 30227 30232 30233 30234 30235 30035 30055 30143 30148 30272 30288 30294 8281 30304 30142 30218 30109 30131 30063 30091 30094 30202 30059 30099 30175 30176 30198 30237 30263 30269 30270 30302 30309 8002 8143 8122 8855 8404 30053 30075 30145 30064 30065 30123 30171 30085 30190 30226 30230 30231 30213 30135 30152 30155 30180 30181 30182 30183 30184 30185 30186 30187 30189 30220 30221 30223 30243 30250 30283 30310 30311 30017 30030 30047 30098 10193. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1854-2024 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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      "reviewStatus": "current",
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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",
        "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-1854-2024",
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            "Field": "Recalling firm",
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            "Field": "Initiated",
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          "item": {
            "Field": "Lot/code info",
            "Value": "UDI-DI:  (1) 782152 N/A (2) 782110 (01)00884838099364(21)  Serial Numbers:  79113 79118 79127 79157 79122 79147 79105 79150 79152 79183 79192 79102 79108 79112 79115 79116 79153 79156 79162 79163 79164 79168 79188 79189 79100 79126 79179 79143 79159 79104 79132 79160 79182 79165 79107 79158 79175 79136 79138 79139 79184 79176 79180 79171 79172 79111 79125 79134 79135 79148 79177 79181 79173 79187 79190 79133 79110 79101 79117 79166 79124 79123 79130 79174 79178 79151 79114 79103 79106 79121 79128 79129 79137 79140 79155 79161 79167 79169 79170 79185    Serial Number:  30199 30200 30201 30062 30191 30240 30241 30242 30305 30315 30125 30088 30113 30222 30252 30268 30028 30038 30058 30069 30081 30095 30100 30117 30118 30138 30164 30167 30168 30169 30170 30192 30197 30207 30209 30217 30228 30246 30248 30249 30256 30262 30267 30281 30284 30289 30297 30298 30306 30307 30312 30314 30210 30219 30245 30254 30276 30029 30043 30052 30061 30083 30101 30107 30114 30115 30116 30119 30120 30122 30130 30137 30140 30153 30154 30158 30159 30160 30163 30173 30174 30177 30178 30179 30196 30203 30251 30253 30259 30265 30266 30277 30279 30280 30282 30285 30291 30293 30104 30105 30216 30244 30290 30308 30316 30070 30208 30102 30112 30133 30206 30214 30224 30238 30261 30264 30274 30295 30303 30051 30084 30149 30215 30227 30232 30233 30234 30235 30035 30055 30143 30148 30272 30288 30294 8281 30304 30142 30218 30109 30131 30063 30091 30094 30202 30059 30099 30175 30176 30198 30237 30263 30269 30270 30302 30309 8002 8143 8122 8855 8404 30053 30075 30145 30064 30065 30123 30171 30085 30190 30226 30230 30231 30213 30135 30152 30155 30180 30181 30182 30183 30184 30185 30186 30187 30189 30220 30221 30223 30243 30250 30283 30310 30311 30017 30030 30047 30098 10193",
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            "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.",
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