SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781260

What Should You Do?

1. Check if you have this product:
   Serial Number Unique Device Identifier (UDI#) 8750 N/A 32245 N/A 9013 N/A 8554 N/A 20211 N/A 18801 N/A 8178 N/A 10164 N/A 8752 N/A 10139 N/A 11076 N/A 8156 N/A 8646 N/A 22116 N/A 21175 N/A 8118 N/A 32443 N/A 32444 N/A 32445 N/A 18561 N/A 18761 N/A 30037 N/A 30146 N/A 21748 N/A 20003 N/A 21384 N/A 20116 N/A 20115 N/A 33220 N/A 18746 (01)00884838095076 8074 (01)00884838095076 18853 (01)00884838095076 21349 (01)00884838095076 18986 (01)00884838095076 18943 (01)00884838095076 18583 (01)00884838095076 22144 (01)00884838095076 22266 (01)00884838095076(21)22266 33045 (01)00884838095076(21)33045 32262 (01)00884838095076(21)32262 11100 (01)00884838095076(21)11100 5572 N/A 10236 N/A 12030 N/A 10183 N/A 72077 N/A 8985 N/A 21466 N/A 8240 N/A 32643 N/A 12084 N/A 8260 N/A 8942 N/A 21912 N/A 32180 N/A 21736 N/A 32059 (01)00884838095076 8917 N/A 10087 N/A 8713 N/A 10130 N/A 32621 N/A 18673 N/A 18701 N/A 30067 N/A 21775 (01)00884838095076 21679 N/A 32086 N/A 22220 N/A 8001 N/A 20070 N/A 10717 N/A 39103 N/A 5523 N/A 10511 N/A 10170 N/A 8642 N/A 21033 N/A 11030 N/A 10061 N/A 11031 N/A 8318 N/A 10174 N/A 18665 N/A 8611 N/A 8084 N/A 10191 N/A 8387 N/A 21932 N/A 8025 N/A 18644 N/A 5463 N/A 21142 N/A 8559 N/A 20057 N/A 11102 N/A 18631 N/A 8804 N/A 18565 N/A 5447 N/A 21015 N/A 10075 N/A 11062 N/A 30045 N/A 32176 N/A 8407 N/A 8512 N/A 8021 N/A 32752 N/A 21676 N/A 11001 N/A 18697 N/A 32710 N/A 32438 N/A 21171 N/A 39031 N/A 10033 N/A 5539 N/A 32636 N/A 21392 N/A 8129 N/A 8397 N/A 11108 N/A 11000 N/A 8704 N/A 13082 N/A 10179 N/A 8263 N/A 10523 N/A 32092 N/A 32113 N/A 32341 N/A 32334 N/A 8110 N/A 18957 N/A 8487 N/A 18938 N/A 32454 N/A 12082 N/A 9020 (01)00884838095076 9024 (01)00884838095076 8736 (01)00884838095076 8885 (01)00884838095076 22194 (01)00884838095076 21018 (01)00884838095076 21814 (01)00884838095076 5484 (01)00884838095076 10117 (01)00884838095076 8476 (01)00884838095076 30097 (01)00884838095076 8315 (01)00884838095076 32163 (01)00884838095076 32099 (01)00884838095076 8401 (01)00884838095076 21082 (01)00884838095076 21453 (01)00884838095076 18013 (01)00884838095076 18906 (01)00884838095076 32164 (01)00884838095076 8321 (01)00884838095076 8486 (01)00884838095076 10008 (01)00884838095076 18894 (01)00884838095076 32322 (01)00884838095076 8175 (01)00884838095076 32340 (01)00884838095076 39018 (01)00884838095076 5425 (01)00884838095076(21)5425 8096 (01)00884838095076(21)8096 8010 N/A 8179 N/A 39003 N/A 21003 N/A 8923 N/A 8087 N/A 8601 N/A 8659 N/A 18690 N/A 8215 N/A 32449 N/A 32127 N/A 32467 (01)00884838095076 8427 N/A 10528 (01)00884838095076 10900 N/A 21768 (01)00884838095076 8862 (01)00884838095076 21710 (01)00884838095076 8081 N/A 8485 N/A 8799 N/A 5490 N/A 5479 N/A 21294 N/A 8819 N/A 8967 N/A 8779 N/A 8746 N/A 8200 N/A 10716 N/A 12047 N/A 21477 N/A 8550 (01)00884838095076 21133 (01)00884838095076 21577 (01)00884838095076 32845 (01)00884838095076(21)32845 21050 N/A 21223 N/A 22154 N/A 21554 N/A 32754 N/A 32049 N/A 22070 N/A 72054 N/A 10079 N/A 20198 N/A 8895 N/A 21880 N/A 8884 N/A 21084 N/A 20151 N/A 20152 N/A 21804 N/A 8492 (01)00884838095076 32807 (01)00884838095076 5505 N/A 5499 N/A 8657 (01)00884838095076 32680 (01)00884838095076 32283 (01)00884838095076 10029 N/A 8054 N/A 8350 N/A 21087 N/A 21737 N/A 18940 N/A 32140 N/A 32361 N/A 21184 N/A 33126 N/A 21942 N/A 11072 N/A 21680 N/A 21691 N/A 33051 N/A 22103 N/A 32822 N/A 21694 N/A 18720 N/A 72081 N/A 21141 N/A 33023 (01)00884838095076 21247 (01)00884838095076 18575 (01)00884838095076 0 N/A 30132 (01)00884838095076(21)30132 18718 N/A 32285 (01)00884838095076(21)32285 21363 N/A 13011 N/A 20132 N/A 21032 N/A 22182 N/A 13052 N/A 9022 N/A 8119 N/A 18655 N/A 20111 N/A 32506 N/A 5466 N/A 21343 N/A 22299 N/A 32450 N/A 8786 N/A 8311 N/A 8395 N/A 9004 N/A 5546 N/A 5537 N/A 8712 N/A 8667 N/A 18101 N/A 10044 N/A 8478 N/A 10457 N/A 18511 N/A 10220 N/A 10554 N/A 0 N/A 11046 N/A 32264 N/A 32410 N/A 32492 N/A 18970 N/A 39037 N/A 8840 N/A 10185 N/A 13001 N/A 8365 N/A 72243 N/A 18509 N/A 33100 N/A 8641 N/A 18597 N/A 21623 N/A 18069 N/A 12036 N/A 8251 N/A 18035 N/A 22055 N/A 21011 N/A 32849 N/A 22296 N/A 32990 N/A 21551 N/A 11017 N/A 20164 N/A 8431 N/A 10552 N/A 8330 N/A 20196 N/A 21362 (01)00884838095076 21892 (01)00884838095076 20413 (01)00884838095076 72239 (01)00884838095076 22044 (01)00884838095076 8045 (01)00884838095076 21890 (01)00884838095076 21809 (01)00884838095076(21)21809 32478 (01)00884838095076(21)32478 8591 N/A 13032 N/A 22227 N/A 8012 N/A 8724 N/A 8949 N/A 13073 N/A 20288 N/A 20263 N/A 21482 N/A 5511 N/A 10208 N/A 8481 N/A 8555 N/A 10498 N/A 11042 N/A 8857 N/A 22098 N/A 13062 N/A 21278 N/A 21129 N/A 9007 N/A 11047 N/A 13029 N/A 18038 N/A 12114 N/A 8896 N/A 11091 N/A 13047 N/A 8057 N/A 12055 N/A 20302 N/A 8309 N/A 21560 N/A 21156 N/A 10906 N/A 10513 N/A 21697 N/A 20033 N/A 13046 N/A 10719 N/A 21759 N/A 20319 N/A 8831 N/A 10913 N/A 18060 N/A 10151 N/A 8060 N/A 21062 N/A 20002 N/A 18929 N/A 8531 N/A 11005 N/A 18107 N/A 20195 N/A 20011 N/A 8843 N/A 20237 N/A 21969 N/A 20278 N/A 21355 N/A 8305 N/A 18704 N/A 21583 N/A 8913 N/A 21222 N/A 20209 N/A 20187 N/A 21780 N/A 8094 N/A 8561 N/A 22013 N/A 8711 N/A 21987 N/A 12120 N/A 10007 N/A 21209 N/A 21182 N/A 21403 N/A 21640 N/A 8887 N/A 18524 N/A 21213 N/A 21519 N/A 21579 N/A 21448 (01)00884838095076 22184 (01)00884838095076 18017 (01)00884838095076 18954 (01)00884838095076 22157 (01)00884838095076 8517 (01)00884838095076 22248 (01)00884838095076 21089 (01)00884838095076 22123 (01)00884838095076 21249 (01)00884838095076 32258 (01)00884838095076(21)32258 32236 (01)00884838095076(21)32236 39009 (01)00884838095076(21)39009 20035 (01)00884838095076(21)20035 22175 (01)00884838095076(21)22175 21326 (01)00884838095076(21)21326 32132 (01)00884838095076(21)32132 10458 N/A 10544 N/A 10915 N/A 21253 N/A 22031 (01)00884838095076(21)22031 18808 N/A 13069 N/A 33352 (01)00884838095076 8091 N/A 18800 N/A 21067 N/A 21481 N/A 18610 N/A 18948 (01)00884838095076 33062 (01)00884838095076 22237 (01)00884838095076 8686 N/A 21023 N/A 8378 N/A 5563 N/A 18663 N/A 21019 N/A 8639 N/A 32742 N/A 20322 N/A 18699 (01)00884838095076 22347 (01)00884838095076 32119 (01)00884838095076(21)32119 8608 N/A 8783 N/A 21960 N/A 8086 N/A 21458 N/A 22189 N/A 21591 N/A 8292 N/A 10543 N/A 32573 (01)00884838095076 8566 N/A 32145 (01)00884838095076 10086 N/A 8983 N/A 18985 (01)00884838095076 21621 (01)00884838095076 22342 N/A 32391 N/A 8723 N/A 22301 N/A 10530 (01)00884838095076 10161 (01)00884838095076(21)10161 21498 N/A 8168 N/A 8451 N/A 18512 N/A 21929 N/A 22285 N/A 8616 N/A 8706 N/A 8687 N/A 32311 N/A 32513 N/A 20112 N/A 32094 N/A 12134 N/A 21888 N/A 32184 N/A 21438 N/A 22060 N/A 8092 N/A 32406 N/A 13018 N/A 8948 N/A 22127 N/A 32221 N/A 32218 N/A 8851 N/A 11085 N/A 12072 N/A 32147 N/A 32374 N/A 32405 N/A 22102 N/A 32296 N/A 22137 (01)00884838095076 22100 (01)00884838095076 8190 N/A 32142 N/A 10570 N/A 11018 N/A 12115 N/A 8392 N/A 22107 N/A 39024 N/A 21290 N/A 10077 N/A 10703 N/A 39005 N/A 8715 N/A 20071 N/A 8996 N/A 21540 N/A 18528 N/A 20226 N/A 8971 N/A 8578 N/A 12033 N/A 32174 N/A 8630 N/A 10196 N/A 21664 N/A 8560 N/A 18559 N/A 32131 N/A 18726 N/A 21108 N/A 8772 N/A 8835 N/A 18558 N/A 10154 N/A 21788 (01)00884838095076 8100 (01)00884838095076 5475 (01)00884838095076 9001 (01)00884838095076 12034 (01)00884838095076 10036 (01)00884838095076 10482 (01)00884838095076 8906 (01)00884838095076 8760 (01)00884838095076 8975 (01)00884838095076(21)8975 8354 N/A 9006 N/A 32200 N/A 8694 (01)00884838095076
2. Do not eat it: Even if it looks and smells fine, do not consume this product.
3. Throw it away or return it: You can return the product to the store for a full refund.
4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
5. Report problems: Report any issues to the FDA's Safety Reporting Portal.