FDAFDA · Food and drugs·Recall number Z-1848-2024
Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782103 (2) 781377 (3) 781342
Published May 29, 2024 · Recall initiated: May 3, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips North America Llc
- Distributor
- 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.
- Lot
- UDI-DI: (1) 782103 (01)00884838098299(21); (2) 781377 (01)00884838009813(21); (3) 781342 (01)00884838055339(21) Serial Numbers: Serial Number 85106 71011 71152 71403 71433 71526 71710 71812 71817 71101 71168 71178 71179 71214 71252 71309 71313 71328 71342 71419 71453 71550 71551 71555 71557 71674 71693 71733 71859 71949 71993 71994 85036 85045 85155 71266 71311 71345 71392 71395 71628 71723 85393 71216 71651 85208 71163 71408 71493 71499 71541 71668 71729 71771 71602 71260 71276 71324 71800 71726 71068 71081 71300 71482 71481 71339 71730 71452 71464 71465 71467 71468 71470 71471 71472 71473 71479 71480 71492 71497 71505 71506 71509 71511 71514 71516 71517 71519 71520 71544 71548 71553 71554 71559 71560 71567 71588 71594 71596 71601 71605 71609 71610 71614 71621 71622 71624 71626 71629 71631 71633 71637 71642 71653 71654 71656 71685 71687 71690 71692 71695 71698 71699 71702 71707 71708 71709 71713 71714 71716 71734 71738 71742 71744 71745 71755 71765 71775 71779 71782 71783 71784 71786 71788 71804 71807 71814 71818 71819 71820 71821 71834 71839 71840 71855 71856 71861 71866 71868 71872 71875 71876 71877 71887 71894 71898 71899 71908 71909 71913 71917 71918 71922 71928 71930 71935 71944 71945 71946 71951 71952 71955 71957 71958 71973 71976 71987 71988 71997 71998 71999 85000 85002 85003 85005 85010 85016 85024 85026 85028 85034 85037 85042 85044 85047 85048 85049 85050 85056 85061 85065 85070 85073 85075 85079 85080 85082 85089 85095 85096 85097 85098 85099 85105 85111 85112 85127 85132 85141 85152 85153 85157 85160 85162 85165 85168 85169 85170 85171 85172 85174 85177 85178 85184 85186 85188 85192 85195 85197 85198 85199 85200 85204 85215 85218 85219 85220 85226 85230 85231 85233 85234 85237 85238 85242 85243 85247 85249 85251 85258 85259 85263 85268 85269 85270 85272 85277 85280 85282 85283 85284 85285 85288 85290 85291 85294 85300 85303 85305 85309 85310 85311 85313 85314 85323 85325 85329 85332 85333 85334 85335 85336 85339 85344 85345 85346 85349 85350 85351 85353 85354 85355 85356 85357 85358 85359 85360 85361 85362 85364 85369 85370 85371 85373 85374 85375 85376 85380 85382 85383 85384 85385 85386 85387 85389 85390 85392 85397 85398 85399 85401 85402 85403 85406 85407 85408 85412 85413 85415 85416 85417 85418 85419 85420 85421 85422 85425 85426 85427 85429 85430 85431 85432 85433 85434 85439 85440 85442 85447 85448 85449 85453 85455 85456 85457 85458 85460 85461 85462 85463 85466 85467 85468 85469 85470 85471 85476 85478 85479 85480 85481 85483 85484 85485 85487 85488 85490 85491 85494 85496 85497 85498 85499 85501 85504 85506 85507 85509 85510 85515 85517 85518 85519 85522 85524 85525 85526 85527 85528 85531 85532 85533 85535 71485 71660 71372 71649 71582 71748 71373 71405 71406 71979 85265 71047 71662 71678 71891 85189 71267 71353 71402 71457 85450 71474 71338 71418 71924 71439 71612 71613 71799 71991 85011 85202 85306 71504 71437 71003 71020 71023 71084 71173 71192 71278 71283 71288 71298 71315 71337 71359 71362 71363 71370 71390 71396 71400 71440 71501 71521 71576 71590 71603 71607 71725 71751 71773 71791 71838 71874 85025 85031 85161 85180 85276 85319 85341 85342 85391 71394 71346 71704 71910 71983 85063 85183 85205 85206 85216 71334 71409 71476 85023 71061 71087 71106 71162 71165 71181 71280 71349 71351 71357 71389 71393 71410 71422 71428 71460 71477 71500 71512 71518 71643 71677 71691 71717 71743 71750 71762 71763 71842 71854 71900 71966 71967 85122 85140 85147 85149 85190 85203 85210 85224 85318 85347 71367 71461 71545 85241 85302 85348 85372 85459 71423 71184 71462 71619 71620 71164 71177 71326 71424 71639 71681 71688 71758 71759 71863 71892 85057 85245 85246 85250 85286 71926 71001 71002 71004 71007 71012 71013 71014 71035 71037 71039 71056 71070 71089 71093 71095 71154 71155 71174 71175 71183 71210 71211 71228 71268 71269 71271 71282 71301 71341 71347 71361 71385 71401 71411 71413 71416 71425 71427 71429 71438 71441 71450 71463 71489 71491 71498 71527 71558 71562 71587 71589 71592 71635 71652 71655 71659 716
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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