Philips North America: Incisive CT-Computed Tomography X-Ray System Model: 728143

Hazard

Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down

Details from the source

Reason for recall: Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down Distribution: Nationwide Foreign: China Algeria Argentina Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Czech Republic Ecuador Egypt France Germany Greece India Indonesia Iran Iraq Israel Italy Japan Jordan Korea, Republic of Kosovo Latvia Macedonia Mexico Moldova Netherlands Nigeria Pakistan Panama Philippines Poland Romania Russian Federati Quantity: 36 US; 610 OUS Lot/code info: UDI-DI: (01) 00884838085015 (21) + Serial number Serial Numbers: 33001 33002 33003 33005 33006 33007 33008 33009 33010 33011 33012 33013 33015 33016 33017 33019 33020 33024 33025 33031 33033 33034 33035 33037 33038 33039 33041 33042 33045 33046 33047 33049 500252 500255 500282 500301 OUS: System Serial Number 530117 33018 33021 33022 33023 33026 33027 33029 33030 33032 33036 33040 33043 33044 500241 500244 500245 500246 500247 500248 500253 500254 500256 500257 500258 500259 500260 500261 500262 500263 500264 500265 500266 500267 500268 500269 500270 500271 500272 500273 500274 500275 500276 500277 500278 500279 500283 500284 500285 500286 500287 500288 500293 500296 500298 500299 500300 500302 500303 500304 500305 500306 500307 500308 500309 500310 500311 500312 500313 500314 500315 500316 500317 500318 500319 500320 500321 500322 500323 500324 500325 500326 500327 500328 500329 500330 500331 500332 500333 500334 500335 500336 500337 500338 500339 500340 500341 500342 500343 500344 500345 500346 500347 500348 500349 500350 500351 500352 500353 500354 500355 500356 500357 500358 500359 500360 500361 500362 500363 500364 500365 500366 500367 500368 500369 500370 500371 500372 500373 500374 500375 500376 500377 500378 500379 500380 500381 500382 500383 500384 500385 500386 500387 500388 500389 500390 500391 500392 500393 500394 500395 500396 500397 500398 500399 500400 500401 500402 500403 500404 500405 500406 500407 500408 500409 500410 500411 500412 500413 500414 500415 50041

UPC codes

00884838085015

Source

Official record: FDA (Device enforcement) ↗

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