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FDA (Device enforcement)Recalled 2024-05-03class ii

Philips North America Llc: Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271

Hazard

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

Details from the source

Reason for recall: 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 Distribution: 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. Quantity: 350 units Lot/code info: UDI-DI: (1) (01)00884838098312(21); (2) (01)00884838068452(21) Serial Number 78121 78150 78157 78096 78208 78094 78012 78074 78154 78161 78170 78171 78172 78173 78182 78183 78189 78190 78196 78198 78205 78210 78212 78213 78216 78218 78221 78225 78233 78235 78238 78240 78241 78242 78243 78244 78250 78251 78252 78253 78256 78257 78262 78263 78265 78266 78267 78268 78269 78270 78271 78272 78273 78279 78280 78281 78282 78283 78284 78288 78289 78291 78292 78293 78294 78295 78296 78301 78305 78306 78307 78308 78309 78310 78312 78313 78314 78316 78317 78319 78320 78321 78322 78323 78327 78328 78329 78330 78332 78333 78334 78335 78338 78339 78340 78341 78342 78343 78345 78346 78347 78352 78353 78354 78356 78357 78358 78359 78360 78361 78362 78363 78364 78366 78368 78370 78374 78375 78376 78377 78386 78078 78080 78224 78098 78003 78017 78065 78070 78076 78081 78087 78097 78099 78101 78104 78107 78126 78149 78151 78181 78206 78219 78264 23032 78063 78064 78106 78187 78000 78005 78007 78009 78010 78015 78016 78018 78019 78021 78023 78025 78027 78029 78031 78032 78033 78035 78038 78039 78040 78042 78043 78045 78048 78049 78050 78051 78062 78067 78068 78072 78082 78083 78084 78088 78089 78091 78095 78100 78109 78111 78113 78114 78115 78117 78127 78129 78132 78133 78139 78140 78145 78147 78148 78155 78199 78203 78207 78214 78222 78223 78004 78008 78053 78011 78013 78014 78028 78034 78044 78046 78047 78058 78060 78066 78071 78073 78075 78077 78086 78092 78102 78103 78110 78112 78118 78120 7

UPC codes

00884838098312, 00884838068452

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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