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U.S. Department of Health and Human Services

Class 2 Device Recall Philips

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  Class 2 Device Recall Philips see related information
Date Initiated by Firm May 03, 2024
Date Posted May 17, 2024
Recall Status1 Open3, Classified
Recall Number Z-1860-2024
Recall Event ID 94508
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product 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;
781260
Code Information 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 22055 22296 22299 8591 18597 5511 8012 8057 8060 8094 8305 8309 8481 8517 8531 8711 8724 8831 8843 8857 8887 8896 8913 8949 9007 10007 10151 10498 10513 10906 10913 11005 11042 11091 12114 12120 13029 13046 13047 13062 13073 18017 18038 18060 18107 18524 18670 18704 18929 20002 20011 20035 20187 20195 20209 20237 20263 20278 20288 20302 20319 21062 21089 21129 21156 21182 21209 21213 21222 21278 21326 21355 21403 21448 21482 21519 21560 21579 21640 21697 21759 21780 21792 21969 21987 22013 22031 22098 22123 22157 22175 22184 22248 10915 10544 21253 8555 21804 18808 22237 8091 10230 11022 12169 18610 18800 18948 21067 21481 8378 8639 8686 18663 18699 20322 21019 21023 21359 22347 8566 8086 8292 8608 8783 10543 21591 21994 21995 10086 8983 18985 21621 8166 8723 10161 10530 22301 22342 8168 8451 21498 18512 21929 22152 21143 21612 8616 8706 20112 10570 11018 8354 8694 9006 13069 5479 5490 8081 8485 8550 8746 8779 8799 8819 9032 10461 10716 12009 12047 21133 21294 21477 21577 8200 8948 11085 12072 12134 13018 21438 21888 22060 22100 22102 22127 22137 8190 8260 8942 12084 21736 8392 12115 20182 22107 8492 8884 8895 10079 20151 20152 20198 21084 21880 5475 8100 8352 8560 8578 8630 8760 8772 8835 8906 8954 8971 8975 9001 10036 10154 10196 10482 10703 12034 18558 18559 18726 20071 20226 21108 21290 21664 21665 18857 21684 32250 8552 18776 21771 21803 22045 22048 32106 32827 33103 33371 33404 75021 18942 21608 21726 22247 32295 32673 32724 33019 30054 32419 32803 32804 33033 72208 72291 22141 8798 10169 10190 10521 12029 13021 21090 21158 21685 21740 22027 32041 39106 75028 75067 8298 18714 18696 10040 18510 32469 21940 32539 8573 10128 20099 20159 21433 21893 22290 32457 32577 32580 32661 32719 32725 32798 33082 75012 8109 8876 10222 12002 18520 18651 18892 18950 18959 20171 21205 21212 21298 21513 21939 22328 32244 32348 32355 32375 32349 32844 8433 30273 32287 33639 32133 21164 32327 32378 33217 10028 30031 13023 21127 21297 33048 72275 18998 22051 22298 32412 33635 32363 32364 8766 32426 22267 22258 32610 32859 39070 10221 20204 39021 13013 21990
Recalling Firm/
Manufacturer		 Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
For Additional Information Contact Customer Care Solution Center
800-722-9377
Manufacturer 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
FDA Determined
Cause 2		 Under Investigation by firm
Action Philips issued Urgent Medical Device Correction notifications to customers on 22-Apr-2024 via FedEx . Philips Markets Organizations are responsible for distributing the letters outside of the US. Letter states reason for recall, health risk and action to take: If a smoke/fire alarm is detected: a. Immediately stop scanning and evacuate the patient and staff from the examination room. b. If a developing fire is detected, adhere to established hospital fire emergency procedures, which may include switching off power to the complete system and/or removing the magnet field by using the Emergency Magnet Off button. c. Do not attempt to continue scanning. d. Immediately contact Philips Service. " Ensure all users are aware of facility specific Emergency Procedures as outlined in Chapter 2: Safety in the Instructions for Use Emergency procedures The User is required to establish emergency procedures for the following situations: " A medical emergency " A fire " An emergency that requires immediate removal of the magnetic field " The release of helium gas into the examination room Philips MRI systems have an Emergency Table Stop button in case there is an emergency during tabletop movement. " Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. " Post this notice near the affected MR system(s) for ease of reference. Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt via email to: pd.cnr@philips.com. Completing this form confirms receipt of the Urgent Medical Device Correction Letter, understanding of the issue, and required actions to be taken. 5. The actions planned by Philips to correct the problem Philips will contact you to schedule time for a Field Service Engineer (FSE) to visit your site to inspect the g-MDU connections in the technical room and apply the proper torque to the connection if necessary.(reference FCO78100582). Philips plans t
Quantity in Commerce 617 units
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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