Philips North America Llc: Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781296 (2) 781343

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: 1585 units Lot/code info: UDI-DI: (01)00884838004108(21) Serial Number 32307 33454 33668 32302 32401 32679 32699 32814 32894 32913 32923 32974 33002 33071 33073 33224 33227 33386 33387 33485 33488 33493 33502 33503 33518 33551 33571 33683 33704 33713 33746 32306 32475 33569 32075 32797 32326 33175 33519 33364 33702 32853 32100 32112 32186 32193 32216 32223 32243 32276 32277 32278 32301 32304 32339 32358 32367 32377 32484 32487 32493 32502 32565 32569 32570 32574 32598 32641 32655 32671 32695 32747 32782 32790 32843 32882 32893 32895 32897 32908 32912 32914 32945 32946 32959 32977 32981 32988 32995 33000 33011 33013 33055 33060 33064 33067 33074 33076 33101 33116 33118 33129 33134 33135 33136 33148 33184 33189 33190 33199 33225 33242 33244 33245 33254 33255 33275 33283 33286 33289 33293 33296 33305 33311 33330 33333 33335 33367 33370 33372 33388 33399 33402 33406 33408 33412 33414 33463 33478 33479 33480 33494 33526 33527 33539 33540 33541 33542 33543 33544 33545 33547 33549 33563 33564 33566 33567 33568 33570 33582 33603 33604 33632 33646 33649 33650 33715 33717 33722 33723 33724 33747 33748 33749 33750 33751 33752 33787 33788 32097 33675 32255 32621 32634 32846 32847 33096 33382 33438 33447 32093 32124 32155 32190 32204 32205 32209 32247 32275 32289 32290 32294 32300 32321 32325 32408 32417 32421 32427 32431 32439 32451 32460 32471 32476 32485 32486 32494 32499 32501 32510 32544 32559 32562 32592 32600 32601 32609 32619 32620 32627 32628 32629 32640 32642 32645 32646 32647 32648 32649 32659 32660 326

UPC codes

00884838004108

Source

Official record: FDA (Device enforcement) ↗

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