Philips North America Llc: 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

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: 1517 units Lot/code info: 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 85

UPC codes

00884838098299, 00884838009813, 00884838055339

Source

Official record: FDA (Device enforcement) ↗

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