Philips North America Llc: SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782146; 782112; 7

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: 617 units Lot/code info: UDI-DI: N/A Serial Numbers: 8750 8554 9013 18574 18801 18988 20211 33385 8646 8156 8178 8752 10139 10164 11076 21379 8118 21175 72250 33044 33246 11100 18583 18746 18853 18965 18986 20003 20115 21138 21349 21384 21748 22144 22266 18561 20116 5572 8240 8734 8808 8985 10183 12030 21466 8713 8917 10087 10130 18673 18701 18803 21775 18872 8090 22220 8087 8215 8601 8923 13026 18690 21003 21458 8427 10528 10900 8862 21333 21710 21768 22255 22256 22257 21050 21554 22070 5425 5447 5463 5484 5536 5539 5550 8001 8010 8025 8084 8096 8129 8175 8179 8263 8318 8321 8387 8397 8401 8407 8456 8476 8559 8611 8642 8704 8736 8804 8885 9020 10008 10033 10061 10075 10117 10170 10174 10179 10191 10717 11000 11001 11030 11031 11102 11108 12082 12121 13082 18013 18565 18631 18644 18697 18894 18906 18938 18957 20057 20070 20160 21015 21018 21020 21082 21142 21171 21453 21814 21932 21979 22194 21033 5523 18665 8512 5499 5505 8657 21296 10029 8054 8350 11064 11072 12053 13011 18575 18718 18720 18940 20032 20055 20206 20295 21004 21087 21091 21141 21184 21210 21223 21247 21261 21347 21451 21555 21576 21582 21611 21680 21691 21694 21737 21739 21755 21863 21912 21942 22017 22018 22086 22093 22103 22224 21801 8213 5466 5537 5546 8045 8311 8330 8365 8395 8424 8431 8478 8641 8667 8712 8786 8840 9004 10044 10102 10220 10457 10552 10554 11017 11046 13001 18069 18101 18509 18511 18548 18655 18788 18970 20111 20132 20164 20165 20196 20413 21011 21032 21362 21551 21565 21623 21671 21746 21809 21890 21892 22044 220

Source

Official record: FDA (Device enforcement) ↗

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