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

Philips North America Llc: Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177

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: 386 units Lot/code info: UDI-DI: (1) 781345 N/A; (2) 781344 N/A; (3) 781278 (01)00884838004139(21); (4) 781277 N/A; (5) 781177 N/A Serial Numbers: 24079 34231 34256 34289 34220 34308 34139 34200 34213 34255 34258 34276 34301 34306 34020 34052 34082 34113 34120 34123 34230 34234 34235 34239 34240 34247 34260 34264 34270 34272 34274 34285 34287 34288 34297 34298 34299 34309 34312 34056 34282 34023 34144 34228 24115 34001 34095 34138 34143 34165 34269 34293 34300 34305 34115 34225 34253 34038 34047 34077 34126 34135 34160 34206 34254 34268 34275 34118 34237 34271 34273 34291 34242 34261 34290 34033 34104 34281 34086 34106 34125 34159 34241 34263 34286 34294 34295 34311 34022 34043 34208 34109 34130 34203 34207 34304 34074 34028 34029 34030 34034 34065 34066 34071 34073 34085 34201 34011 38295 38074 38191 38247 38254 38276 38326 38346 38355 38363 38285 38043 38073 38087 38092 38098 38108 38124 38140 38152 38157 38158 38171 38181 38185 38189 38190 38194 38196 38206 38209 38210 38212 38215 38216 38227 38231 38233 38236 38238 38240 38245 38248 38249 38252 38255 38257 38258 38260 38264 38266 38267 38269 38270 38271 38279 38282 38284 38287 38292 38293 38298 38299 38303 38304 38307 38314 38318 38319 38320 38321 38324 38327 38328 38329 38330 38332 38335 38338 38339 38340 38343 38344 38347 38349 38351 38358 38360 38361 38367 38368 38370 38372 38401 38402 38405 38407 38408 38410 38412 38414 38415 38420 38421 38423 38424 38425 38426 38427 38429 38430 38431 38432 38433 38436 38437 38438 38439 38441 38442 38443 3844

UPC codes

00884838004139

Source

Official record: FDA (Device enforcement)

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

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