| Class 2 Device Recall NeuroStar TMS Therapy System/SenStar Treatment Link | |
Date Initiated by Firm | March 16, 2009 |
Date Posted | May 27, 2009 |
Recall Status1 |
Terminated 3 on May 29, 2009 |
Recall Number | Z-1421-2009 |
Recall Event ID |
51703 |
510(K)Number | K083538 |
Product Classification |
Repetitive transcranial magnetic stimulator for treatment of major depressive disorder - Product Code OBP
|
Product | NeuroStar TMS Therapy System/SenStar Treatment Link.
The SenStar Treatment Link is a single use, disposable component of the NeuroStar TMS system, a non-invasive treatment for depression using highly focused, pulsed magnetic fields to stimulate function in targeted brain regions. |
Code Information |
Catalog Number: 81-50000-000; Serial Numbers: 010615A10 , A10005366 , A10005734 , A10006040 , A10006516 , A10007042 , A10007533 , A10008098 , A10009177 , A10009532 , A10009869 , A10010292 , A10010564 , 010628A10 , A10005367 , A10005735 , A10006041 , A10006517 , A10007043 , A10007534 , A10008099 , A10009178 , A10009533 , A10009870 , A10010293 , A10010565 , 010635A10 , A10005368 , A10005738 , A10006042 , A10006518 , A10007043 , A10007535 , A10008100 , A10009179 , A10009534 , A10009871 , A10010294 , A10010566 , 010639A10 , A10005369 , A10005739 , A10006043 , A10006519 , A10007044 , A10007536 , A10008101 , A10009180 , A10009535 , A10009872 , A10010295 , A10010567 , 010644A10 , A10005370 , A10005747 , A10006044 , A10006520 , A10007044 , A10007537 , A10008102 , A10009181 , A10009536 , A10009873 , A10010296 , A10010573 , 010645A10 , A10005371 , A10005748 , A10006045 , A10006521 , A10007045 , A10007538 , A10008103 , A10009182 , A10009537 , A10009874 , A10010297 , A10010574 , 010646A10 , A10005372 , A10005749 , A10006046 , A10006522 , A10007045 , A10007539 , A10008104 , A10009183 , A10009538 , A10009875 , A10010298 , A10010575 , 010652A10 , A10005373 , A10005750 , A10006047 , A10006523 , A10007046 , A10007540 , A10008105 , A10009184 , A10009539 , A10009876 , A10010299 , A10010576 , 010653A10 , A10005374 , A10005751 , A10006048 , A10006524 , A10007046 , A10007541 , A10008106 , A10009185 , A10009540 , A10009877 , A10010300 , A10010577 , 010654A10 , A10005375 , A10005752 , A10006049 , A10006525 , A10007047 , A10007542 , A10008107 , A10009186 , A10009545 , A10009878 , A10010301 , A10010583 , 010658A10 , A10005376 , A10005753 , A10006050 , A10006526 , A10007047 , A10007543 , A10008108 , A10009187 , A10009546 , A10009879 , A10010302 , A10010584 , 010659A10 , A10005378 , A10005754 , A10006051 , A10006530 , A10007048 , A10007544 , A10008159 , A10009188 , A10009547 , A10009880 , A10010303 , A10010585 , 010662A10 , A10005379 , A10005755 , A10006052 , A10006531 , A10007048 , 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010769A10 , A10005405 , A10005797 , A10006079 , A10006564 , A10007061 , A10007571 , A10008186 , A10009219 , A10009619 , A10009907 , A10010330 , A10010691 , 010770A10 , A10005406 , A10005799 , A10006080 , A10006565 , A10007062 , A10007572 , A10008187 , A10009220 , A10009620 , A10009908 , A10010331 , A10010693 , 010771A10 , A10005407 , A10005800 , A10006081 , A10006566 , A10007062 , A10007573 , A10008196 , A10009221 , A10009621 , A10009909 , A10010332 , A10010701 , 010787A10 , A10005408 , A10005801 , A10006082 , A10006567 , A10007063 , A10007574 , A10008209 , A10009222 , A10009622 , A10009910 , A10010333 , A10010702 , 010790A10 , A10005409 , A10005803 , A10006083 , A10006568 , A10007063 , A10007575 , A10008210 , A10009223 , A10009623 , A10009911 , A10010334 , A10010704 , 010806A10 , A10005410 , A10005804 , A10006084 , A10006569 , A10007074 , A10007576 , A10008211 , A10009224 , A10009624 , A10009912 , A10010335 , A10010705 , 010810A10 , A10005411 , A10005807 , A10006085 , A10006570 , A10007075 , A10007577 , A10008212 , A10009225 , A10009625 , A10009913 , A10010336 , A10010706 , 010814A10 , A10005412 , A10005808 , A10006086 , A10006571 , A10007076 , A10007578 , A10008213 , A10009226 , A10009626 , A10009914 , A10010337 , A10010716 , 010847A10 , A10005413 , A10005812 , A10006087 , A10006572 , A10007077 , A10007579 , A10008229 , A10009227 , A10009627 , A10009915 , A10010338 , A10010724 , 010848A10 . A10005414 , A10005813 , A10006088 , A10006573 , A10007078 , A10007580 , A10008230 , A10009228 , A10009628 , A10009916 , A10010339 , A10010727 , 010861A10 , A10005415 , A10005814 , A10006089 , A10006574 , A10007079 , A10007581 , A10008231 , A10009229 , A10009629 , A10009917 , A10010340 , A10010730 , 010863A10 , A10005416 , A10005815 , A10006090 , A10006575 , A10007080 , A10007582 , A10008232 , A10009230 , A10009630 , A10009918 , A10010341 , A10010742 , 010897A10 , A10005417 , A10005816 , A10006091 , A10006576 , A10007081 , A10007583 , A10008233 , A10009231 , A10009631 , A10009919 , A10010342 , A10010745 , 010973A10 , A10005418 , A10005817 , A10006092 , A10006577 , A10007082 , A10007584 , A10008248 , A10009232 , A10009632 , A10009920 , A10010343 , A10010748 , 010974A10 , A10005419 , A10005818 , A10006093 , A10006578 , A10007083 , A10007585 , A10008249 , A10009233 , A10009633 , A10009921 , A10010344 , A10010753 , 010975A10 , A10005420 , A10005819 , A10006094 , A10006579 , A10007084 , 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A10006107 , A10006602 , A10007109 , A10007609 , A10008271 , A10009247 , A10009647 , A10010108 , A10010358 , A10010835 , A10005054 , A10005434 , A10005833 , A10006108 , A10006603 , A10007110 , A10007610 , A10008272 , A10009248 , A10009648 , A10010109 , A10010359 , A10010843 , A10005055 , A10005435 , A10005834 , A10006109 , A10006604 , A10007111 , A10007613 , A10008273 , A10009249 , A10009649 , A10010110 , A10010360 , A10010845 , A10005058 , A10005436 , A10005835 , A10006110 , A10006615 , A10007112 , A10007614 , A10008274 , A10009250 , A10009650 , A10010111 , A10010361 , A10010849 , A10005059 , A10005437 , A10005836 , A10006111 , A10006616 , A10007113 , A10007615 , A10008297 , A10009251 , A10009651 , A10010112 , A10010362 , A10010850 , A10005060 , A10005438 , A10005837 , A10006112 , A10006617 , A10007141 , A10007616 , A10008298 , A10009252 , A10009652 , A10010113 , A10010363 , A10010851 , A10005062 , A10005439 , A10005838 , A10006113 , A10006628 , A10007142 , A10007617 , A10008313 , A10009253 , A10009653 , A10010114 , A10010364 , A10010854 , A10005063 , A10005440 , A10005842 , A10006114 , A10006629 , A10007143 , A10007618 , A10008314 , A10009254 , A10009654 , A10010115 , A10010365 , A10010855 , A10005064 , A10005441 , A10005843 , A10006115 , A10006630 , A10007144 , A10007619 , A10008315 , A10009255 , A10009655 , A10010116 , A10010366 , A10010859 , A10005065 , A10005442 , A10005844 , A10006116 , A10006631 , A10007145 , A10007620 , A10008316 , A10009256 , A10009656 , A10010117 , A10010367 , A10010862 , A10005066 , A10005443 , A10005845 , A10006117 , A10006632 , A10007155 , A10007621 , A10008317 , A10009257 , A10009657 , A10010118 , A10010368 , A10010865 , A10005067 , A10005444 , A10005846 , A10006118 , A10006633 , A10007156 , A10007622 , A10008323 , A10009258 , A10009658 , A10010119 , A10010369 , A10010871 , A10005068 , A10005445 , A10005847 , A10006119 , A10006634 , A10007157 , A10007623 , A10008324 , A10009259 , A10009659 , A10010120 , A10010370 , A10010876 , A10005069 , A10005446 , A10005848 , A10006120 , A10006635 , A10007158 , A10007624 , A10008325 , A10009260 , A10009660 , A10010121 , A10010371 , A10010877 , A10005070 , A10005447 , A10005849 , A10006121 , A10006636 , A10007159 , A10007625 , A10008326 , A10009261 , A10009661 , A10010122 , A10010372 , A10010878 , A10005073 , A10005448 , A10005850 , A10006122 , A10006637 , A10007160 , A10007626 , A10008327 , A10009262 , A10009662 , A10010123 , A10010373 , A10010879 , A10005074 , A10005449 , A10005851 , A10006123 , A10006638 , A10007161 , A10007627 , A10008328 , A10009263 , A10009663 , A10010124 , A10010374 , A10010888 , A10005086 , A10005450 , A10005852 , A10006124 , A10006639 , A10007162 , A10007628 , A10008329 , A10009264 , A10009664 , A10010125 , A10010375 , A10010892 , A10005087 , A10005451 , A10005853 , A10006125 , A10006640 , A10007163 , A10007629 , A10008330 , A10009265 , A10009665 , A10010126 , A10010376 , A10010893 , A10005091 , A10005453 , A10005854 , A10006126 , A10006641 , A10007164 , A10007631 , A10008331 , A10009266 , A10009666 , A10010127 , A10010377 , A10010894 , A10005099 , A10005454 , A10005855 , A10006127 , A10006644 , A10007165 , A10007632 , A10008333 , A10009267 , A10009667 , A10010128 , A10010378 , A10010898 , A10005102 , A10005455 , A10005856 , A10006128 , A10006645 , A10007166 , A10007633 , A10008334 , A10009268 , A10009668 , A10010129 , A10010379 , A10010900 , A10005104 , A10005456 , A10005857 , A10006129 , A10006646 , A10007178 , A10007634 , A10008335 , A10009269 , A10009669 , A10010130 , A10010380 , A10010920 , A10005106 , A10005457 , A10005858 , A10006130 , A10006647 , A10007179 , A10007636 , A10008336 , A10009270 , A10009670 , A10010131 , A10010381 , A10010924 , A10005112 , A10005458 , A10005859 , A10006131 , A10006648 , A10007180 , A10007637 , A10008337 , A10009271 , A10009671 , A10010132 , A10010382 , A10010930 , A10005116 , A10005459 , A10005860 , A10006132 , A10006649 , A10007181 , A10007638 , A10008338 , A10009272 , A10009672 , A10010133 , A10010383 , A10010937 , A10005117 , A10005460 , A10005861 , A10006133 , A10006650 , A10007182 , A10007639 , A10008339 , A10009273 , A10009673 , A10010134 , A10010384 , A10010942 , A10005121 , A10005461 , A10005862 , A10006134 , A10006651 , A10007183 , A10007640 , A10008340 , A10009274 , A10009674 , A10010135 , A10010385 , A10010947 , A10005125 , A10005462 , A10005863 , A10006135 , A10006652 , A10007184 , A10007641 , A10008341 , A10009275 , A10009675 , A10010136 , A10010386 , A10010951 , A10005126 , A10005463 , A10005864 , A10006136 , A10006653 , A10007185 , A10007643 , A10008357 , A10009276 , A10009676 , A10010137 , A10010387 , A10010952 , A10005127 , A10005464 , A10005865 , A10006137 , A10006654 , A10007186 , A10007644 , A10008358 , A10009277 , A10009677 , A10010138 , A10010388 , A10010956 , A10005130 , A10005465 , A10005866 , A10006138 , A10006655 , A10007187 , A10007645 , A10008359 , A10009278 , A10009678 , A10010139 , A10010389 , A10010958 , A10005131 , A10005466 , A10005867 , A10006139 , A10006656 , A10007193 , A10007646 , A10008360 , A10009279 , A10009679 , A10010140 , A10010390 , A10010962 , A10005132 , A10005467 , A10005868 , A10006140 , A10006657 , A10007229 , A10007647 , A10008361 , A10009280 , A10009680 , A10010141 , A10010391 , A10010963 , A10005133 , A10005468 , A10005869 , A10006141 , A10006659 , A10007230 , A10007653 , A10008362 , A10009281 , A10009681 , A10010142 , A10010392 , A10010964 , A10005134 , A10005469 , A10005870 , A10006142 , A10006660 , A10007231 , A10007654 , A10008363 , A10009282 , A10009682 , A10010143 , A10010393 , A10010965 , A10005135 , A10005471 , A10005871 , A10006143 , A10006661 , A10007232 , A10007655 , A10008364 , A10009283 , A10009683 , A10010144 , A10010394 , A10010966 , A10005136 , A10005472 , A10005872 , A10006144 , A10006662 , A10007233 , A10007656 , A10008365 , A10009284 , A10009684 , A10010145 , A10010395 , A10010967 , A10005137 , A10005473 , A10005873 , A10006145 , A10006663 , A10007303 , A10007657 , A10008368 , A10009285 , A10009685 , A10010146 , A10010396 , A10010972 , A10005140 , A10005474 , A10005874 , A10006146 , A10006664 , A10007304 , A10007658 , A10008369 , A10009286 , A10009686 , A10010147 , A10010397 , A10011382 , A10005141 , A10005475 , A10005875 , A10006147 , A10006665 , A10007305 , A10007659 , A10008370 , A10009287 , A10009687 , A10010148 , A10010398 , A10011383 , A10005142 , A10005476 , A10005876 , A10006148 , A10006666 , A10007306 , A10007660 , A10008371 , A10009303 , A10009688 , A10010149 , A10010399 , A10011384 , A10005143 , A10005477 , A10005877 , A10006149 , A10006671 , A10007322 , A10007661 , A10008372 , A10009304 , A10009689 , A10010150 , A10010400 , A10011396 , A10005145 , A10005478 , A10005878 , A10006150 , A10006672 , A10007322 , A10007662 , A10008373 , A10009305 , A10009690 , A10010151 , A10010401 , A10011397 , A10005146 , A10005479 , A10005879 , A10006151 , A10006673 , A10007323 , A10007663 , A10008374 , A10009306 , A10009691 , A10010152 , A10010402 , A10011401 , A10005147 , A10005480 , A10005880 , A10006152 , A10006674 , A10007323 , A10007664 , A10008375 , A10009307 , A10009692 , A10010153 , A10010403 , A10011402 , A10005148 , A10005481 , A10005881 , A10006153 , A10006675 , A10007324 , A10007665 , A10008376 , A10009308 , A10009693 , A10010154 , A10010404 , A10011403 , A10005149 , A10005482 , A10005882 , A10006154 , A10006676 , A10007324 , A10007666 , A10008377 , A10009309 , A10009694 , A10010155 , A10010405 , A10011452 , A10005150 , A10005483 , A10005883 , A10006155 , A10006677 , A10007325 , A10007667 , A10008378 , A10009310 , A10009695 , A10010156 , A10010406 , A10011453 , A10005151 , A10005484 , A10005884 , A10006156 , A10006678 , A10007325 , A10007711 , A10008379 , A10009311 , A10009696 , A10010157 , A10010407 , A10011454 , A10005152 , A10005485 , A10005885 , A10006157 , A10006679 , A10007326 , A10007712 , A10008380 , A10009312 , A10009697 , A10010158 , A10010408 , A10011458 , A10005153 , A10005486 , A10005886 , A10006158 , A10006680 , A10007326 , A10007713 , A10008381 , A10009313 , A10009698 , A10010159 , A10010409 , A10011463 , A10005155 , A10005487 , A10005887 , A10006159 , A10006681 , A10007332 , A10007714 , A10008382 , A10009314 , A10009699 , A10010160 , A10010410 , A10011896 , A10005156 , A10005488 , A10005888 , A10006160 , A10006682 , A10007333 , A10007747 , A10008383 , A10009315 , A10009700 , A10010161 , A10010411 , A10011897 , A10005157 , A10005489 , A10005889 , A10006161 , A10006683 , A10007334 , A10007748 , A10008384 , A10009316 , A10009701 , A10010162 , A10010412 , A10012044 , A10005158 , A10005490 , A10005890 , A10006162 , A10006684 , A10007335 , A10007749 , A10008385 , A10009317 , A10009702 , A10010163 , A10010413 , A10012046 , A10005159 , A10005491 , A10005891 , A10006163 , A10006685 , A10007336 , A10007750 , A10008386 , A10009318 , A10009703 , A10010164 , A10010414 , A10012047 , A10005160 , A10005492 , A10005892 , A10006164 , A10006686 , A10007342 , A10007751 , A10008387 , A10009319 , A10009704 , A10010165 , A10010415 , A10005161 , A10005493 , A10005893 , A10006165 , A10006687 , A10007343 , A10007752 , A10008388 , A10009320 , A10009705 , A10010166 , A10010416 , A10005162 , A10005494 , A10005894 , A10006166 , A10006691 , A10007344 , A10007753 , A10008389 , A10009321 , A10009706 , A10010167 , A10010417 , A10005163 , A10005495 , A10005895 , A10006168 , A10006707 , A10007345 , A10007754 , A10008390 , A10009322 , A10009707 , A10010168 , A10010418 , A10005172 , A10005496 , A10005896 , A10006169 , A10006708 , A10007346 , A10007755 , A10008391 , A10009323 , A10009708 , A10010169 , A10010419 , A10005173 , A10005497 , A10005897 , A10006170 , A10006709 , A10007347 , A10007756 , A10008392 , A10009324 , A10009709 , A10010170 , A10010420 , A10005174 , A10005498 , A10005898 , A10006171 , A10006756 , A10007347 , A10007757 , A10008393 , A10009325 , A10009710 , A10010171 , A10010421 , A10005180 , A10005499 , A10005899 , A10006172 , A10006757 , A10007348 , A10007758 , A10008394 , A10009326 , A10009711 , A10010172 , A10010422 , A10005181 , A10005501 , A10005900 , A10006173 , A10006758 , A10007348 , A10007759 , A10008395 , A10009327 , A10009712 , A10010173 , A10010423 , A10005182 , A10005503 , A10005901 , A10006174 , A10006759 , A10007349 , A10007760 , A10008396 , A10009328 , A10009713 , A10010174 , A10010424 , A10005183 , A10005504 , A10005902 , A10006175 , A10006760 , A10007349 , A10007761 , A10008397 , A10009329 , A10009714 , A10010175 , A10010425 , A10005184 , A10005505 , A10005903 , A10006176 , A10006761 , A10007350 , A10007762 , A10008398 , A10009330 , A10009715 , A10010176 , A10010426 , A10005185 , A10005509 , A10005904 , A10006177 , A10006762 , A10007350 , A10007763 , A10008399 , A10009331 , A10009716 , A10010177 , A10010427 , A10005186 , A10005510 , A10005905 , A10006178 , A10006767 , A10007351 , A10007764 , A10008400 , A10009332 , A10009717 , A10010178 , A10010428 , A10005187 , A10005511 , A10005906 , A10006179 , A10006768 , A10007351 , A10007928 , A10008401 , A10009333 , A10009718 , A10010179 , A10010429 , A10005188 , A10005512 , A10005908 , A10006180 , A10006811 , A10007352 , A10007929 , A10008407 , A10009334 , A10009719 , A10010180 , A10010430 , A10005189 , A10005514 , A10005914 , A10006181 , A10006812 , A10007353 , A10007930 , A10008408 , A10009335 , A10009720 , A10010181 , A10010431 , A10005190 , A10005515 , A10005915 , A10006182 , A10006813 , A10007354 , A10007931 , A10008500 , A10009336 , A10009721 , A10010182 , A10010432 , A10005191 , A10005516 , A10005916 , A10006183 , A10006814 , A10007355 , A10007932 , A10008501 , A10009337 , A10009722 , A10010183 , A10010433 , A10005192 , A10005518 , A10005917 , A10006184 , A10006815 , A10007356 , A10007933 , A10008502 , A10009338 , A10009723 , A10010184 , A10010434 , A10005193 , A10005519 , A10005918 , A10006185 , A10006852 , A10007357 , A10007934 , A10008503 , A10009339 , A10009724 , A10010185 , A10010435 , A10005194 , A10005523 , A10005919 , A10006186 , A10006858 , A10007358 , A10007935 , A10008504 , A10009340 , A10009725 , A10010186 , A10010436 , A10005195 , A10005525 , A10005923 , A10006187 , A10006859 , A10007359 , A10007936 , A10008505 , A10009341 , A10009726 , A10010187 , A10010437 , A10005196 , A10005526 , A10005925 , A10006188 , A10006860 , A10007360 , A10007937 , A10008506 , A10009342 , A10009727 , A10010188 , A10010438 , A10005197 , A10005529 , A10005931 , A10006189 , A10006861 , A10007362 , A10007938 , A10008507 , A10009343 , A10009728 , A10010189 , A10010439 , A10005198 , A10005533 , A10005932 , A10006209 , A10006862 , A10007363 , A10007939 , A10008508 , A10009344 , A10009729 , A10010190 , A10010440 , A10005199 , A10005546 , A10005938 , A10006210 , A10006873 , A10007364 , A10007940 , A10008509 , A10009345 , A10009730 , A10010191 , A10010441 , A10005200 , A10005547 , A10005939 , A10006211 , A10006874 , A10007365 , A10007941 , A10008510 , A10009346 , A10009731 , A10010192 , A10010442 , A10005201 , A10005548 , A10005940 , A10006212 , A10006875 , A10007366 , A10007942 , A10008511 , A10009347 , A10009732 , A10010193 , A10010443 , A10005202 , A10005549 , A10005941 , A10006213 , A10006876 , A10007367 , A10007943 , A10008512 , A10009348 , A10009733 , A10010194 , A10010444 , A10005203 , A10005550 , A10005942 , A10006214 , A10006877 , A10007377 , A10007944 , A10008513 , A10009349 , A10009734 , A10010195 , A10010445 , A10005209 , A10005551 , A10005943 , A10006215 , A10006878 , A10007377 , A10007945 , A10008514 , A10009350 , A10009735 , A10010196 , A10010446 , A10005210 , A10005576 , A10005944 , A10006216 , A10006885 , A10007378 , A10007946 , A10008515 , A10009351 , A10009736 , A10010197 , A10010447 , A10005211 , A10005577 , A10005945 , A10006217 , A10006886 , A10007378 , A10007947 , A10008516 , A10009352 , A10009737 , A10010198 , A10010448 , A10005226 , A10005583 , A10005946 , A10006218 , A10006887 , A10007379 , A10007948 , A10008517 , A10009353 , A10009738 , A10010199 , A10010449 , A10005227 , A10005596 , A10005947 , A10006219 , A10006888 , A10007379 , A10007953 , A10008518 , A10009354 , A10009739 , A10010200 , A10010450 , A10005228 , A10005597 , A10005948 , A10006220 , A10006888 , A10007380 , A10007954 , A10008520 , A10009355 , A10009740 , A10010201 , A10010451 , A10005229 , A10005598 , A10005949 , A10006221 , A10006889 , A10007380 , A10007955 , A10008521 , A10009356 , A10009741 , A10010202 , A10010452 , A10005230 , A10005599 , A10005950 , A10006222 , A10006889 , A10007381 , A10007956 , A10008522 , A10009357 , A10009742 , A10010203 , A10010453 , A10005231 , A10005600 , A10005951 , A10006223 , A10006890 , A10007381 , A10007957 , A10008523 , A10009358 , A10009743 , A10010204 , A10010454 , A10005232 , A10005601 , A10005952 , A10006232 , A10006890 , A10007388 , A10007958 , A10008524 , A10009359 , A10009744 , A10010205 , A10010455 , A10005233 , A10005602 , A10005953 , A10006233 , A10006891 , A10007389 , A10007959 , A10008525 , A10009360 , A10009745 , A10010206 , A10010456 , A10005234 , A10005603 , A10005954 , A10006234 , A10006891 , A10007390 , A10007960 , A10008526 , A10009361 , A10009746 , A10010207 , A10010457 , A10005235 , A10005604 , A10005955 , A10006235 , A10006892 , A10007391 , A10007970 , A10008527 , A10009362 , A10009747 , A10010208 , A10010458 , A10005236 , A10005605 , A10005956 , A10006236 , A10006892 , A10007392 , A10007971 , A10008528 , A10009363 , A10009748 , A10010209 , A10010459 , A10005237 , A10005606 , A10005957 , A10006237 , A10006893 , A10007393 , A10007972 , A10008529 , A10009364 , A10009749 , A10010210 , A10010460 , A10005238 , A10005607 , A10005958 , A10006238 , A10006893 , A10007394 , A10007973 , A10008530 , A10009365 , A10009750 , A10010211 , A10010461 , A10005239 , A10005608 , A10005959 , A10006239 , A10006894 , A10007395 , A10007974 , A10008531 , A10009366 , A10009751 , A10010212 , A10010462 , A10005240 , A10005609 , A10005960 , A10006240 , A10006894 , A10007427 , A10007975 , A10008532 , A10009367 , A10009752 , A10010213 , A10010463 , A10005241 , A10005610 , A10005961 , A10006241 , A10006895 , A10007427 , A10007976 , A10008533 , A10009368 , A10009753 , A10010214 , A10010464 , A10005242 , A10005611 , A10005962 , A10006242 , A10006895 , A10007428 , A10007977 , A10008534 , A10009369 , A10009754 , A10010215 , A10010465 , A10005243 , A10005612 , A10005963 , A10006243 , A10006896 , A10007428 , A10007978 , A10008535 , A10009370 , A10009755 , A10010216 , A10010466 , A10005244 , A10005613 , A10005964 , A10006244 , A10006896 , A10007429 , A10007979 , A10008536 , A10009371 , A10009756 , A10010217 , A10010467 , A10005245 , A10005614 , A10005965 , A10006245 , A10006897 , A10007429 , A10007980 , A10008537 , A10009372 , A10009757 , A10010218 , A10010468 , A10005246 , A10005615 , A10005966 , A10006246 , A10006897 , A10007430 , A10007981 , A10008538 , A10009373 , A10009758 , A10010219 , A10010469 , A10005247 , A10005616 , A10005967 , A10006247 , A10006898 , A10007430 , A10007982 , A10008539 , A10009374 , A10009759 , A10010220 , A10010470 , A10005250 , A10005617 , A10005968 , A10006248 , A10006898 , A10007431 , A10007983 , A10008546 , A10009375 , A10009760 , A10010221 , A10010471 , A10005251 , A10005618 , A10005969 , A10006249 , A10006900 , A10007431 , A10007984 , A10008547 , A10009376 , A10009761 , A10010222 , A10010472 , A10005252 , A10005619 , A10005970 , A10006250 , A10006900 , A10007437 , A10007985 , A10008548 , A10009377 , A10009762 , A10010223 , A10010473 , A10005273 , A10005620 , A10005971 , A10006251 , A10006979 , A10007464 , A10007986 , A10008549 , A10009378 , A10009763 , A10010224 , A10010474 , A10005274 , A10005621 , A10005972 , A10006252 , A10006980 , A10007464 , A10007987 , A10008550 , A10009379 , A10009764 , A10010225 , A10010475 , A10005275 , A10005622 , A10005973 , A10006253 , A10006985 , A10007465 , A10007988 , A10008551 , A10009380 , A10009765 , A10010226 , A10010476 , A10005276 , A10005623 , A10005974 , A10006254 , A10006985 , A10007465 , A10007989 , A10008552 , A10009381 , A10009766 , A10010227 , A10010477 , A10005281 , A10005629 , A10005975 , A10006255 , A10006986 , A10007466 , A10007990 , A10008553 , A10009382 , A10009767 , A10010228 , A10010478 , A10005282 , A10005630 , A10005976 , A10006256 , A10006986 , A10007466 , A10007991 , A10008554 , A10009383 , A10009768 , A10010229 , A10010479 , A10005283 , A10005632 , A10005977 , A10006257 , A10006987 , A10007467 , A10007992 , A10008555 , A10009384 , A10009769 , A10010230 , A10010480 , A10005303 , A10005636 , A10005978 , A10006258 , A10006987 , A10007467 , A10007993 , A10008556 , A10009385 , A10009770 , A10010231 , A10010481 , A10005304 , A10005638 , A10005979 , A10006259 , A10006988 , A10007468 , A10007994 , A10008557 , A10009386 , A10009771 , A10010232 , A10010482 , A10005305 , A10005639 , A10005980 , A10006260 , A10006988 , A10007468 , A10007995 , A10008573 , A10009392 , A10009772 , A10010233 , A10010483 , A10005306 , A10005640 , A10005981 , A10006261 , A10006989 , A10007469 , A10007996 , A10008574 , A10009393 , A10009773 , A10010234 , A10010484 , A10005307 , A10005641 , A10005982 , A10006262 , A10006989 , A10007470 , A10007997 , A10008575 , A10009394 , A10009774 , A10010235 , A10010485 , A10005308 , A10005645 , A10005983 , A10006263 , A10006990 , A10007471 , A10007998 , A10008576 , A10009395 , A10009775 , A10010236 , A10010493 , A10005309 , A10005646 , A10005984 , A10006264 , A10006990 , A10007472 , A10007999 , A10008577 , A10009396 , A10009776 , A10010237 , A10010494 , A10005310 , A10005648 , A10005985 , A10006265 , A10006991 , A10007473 , A10008000 , A10008580 , A10009397 , A10009777 , A10010238 , A10010495 , A10005311 , A10005651 , A10005986 , A10006266 , A10006991 , A10007474 , A10008001 , A10008581 , A10009398 , A10009778 , A10010239 , A10010496 , A10005312 , A10005652 , A10005987 , A10006267 , A10006992 , A10007475 , A10008002 , A10008582 , A10009399 , A10009779 , A10010240 , A10010497 , A10005313 , A10005653 , A10005988 , A10006268 , A10006992 , A10007476 , A10008003 , A10008583 , A10009400 , A10009780 , A10010241 , A10010498 , A10005314 , A10005654 , A10005989 , A10006269 , A10006993 , A10007477 , A10008005 , A10008584 , A10009401 , A10009781 , A10010242 , A10010499 , A10005315 , A10005655 , A10005990 , A10006270 , A10006993 , A10007478 , A10008009 , A10008596 , A10009402 , A10009782 , A10010243 , A10010500 , A10005316 , A10005657 , A10005991 , A10006271 , A10006994 , A10007479 , A10008010 , A10008597 , A10009403 , A10009783 , A10010244 , A10010501 , A10005317 , A10005658 , A10005992 , A10006272 , A10006994 , A10007485 , A10008011 , A10008598 , A10009405 , A10009784 , A10010245 , A10010502 , A10005318 , A10005663 , A10005993 , A10006273 , A10006995 , A10007485 , A10008012 , A10008599 , A10009406 , A10009785 , A10010246 , A10010503 , A10005319 , A10005664 , A10005994 , A10006274 , A10006995 , A10007486 , A10008013 , A10008600 , A10009407 , A10009786 , A10010247 , A10010504 , A10005320 , A10005666 , A10005995 , A10006275 , A10006996 , A10007486 , A10008014 , A10008601 , A10009408 , A10009787 , A10010248 , A10010505 , A10005321 , A10005667 , A10005996 , A10006276 , A10006996 , A10007487 , A10008015 , A10008602 , A10009409 , A10009788 , A10010249 , A10010506 , A10005322 , A10005668 , A10005997 , A10006447 , A10006997 , A10007487 , A10008016 , A10008603 , A10009419 , A10009789 , A10010250 , A10010507 , A10005323 , A10005669 , A10005998 , A10006448 , A10006997 , A10007488 , A10008017 , A10008604 , A10009420 , A10009790 , A10010251 , A10010508 , A10005324 , A10005670 , A10005999 , A10006449 , A10006998 , A10007488 , A10008018 , A10008605 , A10009421 , A10009791 , A10010252 , A10010509 , A10005325 , A10005674 , A10006000 , A10006450 , A10006998 , A10007489 , A10008024 , A10008606 , A10009422 , A10009792 , A10010253 , A10010510 , A10005326 , A10005676 , A10006001 , A10006451 , A10006999 , A10007489 , A10008025 , A10008607 , A10009423 , A10009793 , A10010254 , A10010511 , A10005327 , A10005678 , A10006002 , A10006452 , A10007000 , A10007490 , A10008026 , A10008615 , A10009424 , A10009794 , A10010255 , A10010512 , A10005328 , A10005680 , A10006003 , A10006453 , A10007001 , A10007490 , A10008027 , A10008616 , A10009425 , A10009795 , A10010256 , A10010513 , A10005329 , A10005681 , A10006004 , A10006454 , A10007002 , A10007491 , A10008028 , A10008617 , A10009426 , A10009796 , A10010257 , A10010514 , A10005330 , A10005682 , A10006005 , A10006455 , A10007003 , A10007491 , A10008029 , A10008618 , A10009427 , A10009797 , A10010258 , A10010515 , A10005331 , A10005683 , A10006006 , A10006456 , A10007004 , A10007492 , A10008030 , A10008619 , A10009428 , A10009798 , A10010259 , A10010516 , A10005332 , A10005684 , A10006007 , A10006457 , A10007004 , A10007492 , A10008031 , A10008626 , A10009433 , A10009799 , A10010260 , A10010517 , A10005333 , A10005685 , A10006008 , A10006484 , A10007005 , A10007493 , A10008032 , A10008629 , A10009434 , A10009800 , A10010261 , A10010518 , A10005334 , A10005686 , A10006009 , A10006485 , A10007005 , A10007493 , A10008033 , A10008630 , A10009435 , A10009801 , A10010262 , A10010519 , A10005335 , A10005687 , A10006010 , A10006486 , A10007006 , A10007494 , A10008034 , A10008631 , A10009436 , A10009802 , A10010263 , A10010520 , A10005336 , A10005688 , A10006011 , A10006487 , A10007006 , A10007494 , A10008035 , A10008632 , A10009437 , A10009803 , A10010264 , A10010521 , A10005337 , A10005689 , A10006012 , A10006488 , A10007007 , A10007500 , A10008036 , A10008633 , A10009482 , A10009804 , A10010265 , A10010522 , A10005338 , A10005690 , A10006013 , A10006489 , A10007007 , A10007501 , A10008037 , A10008634 , A10009483 , A10009805 , A10010266 , A10010523 , A10005339 , A10005691 , A10006014 , A10006490 , A10007008 , A10007507 , A10008038 , A10008635 , A10009492 , A10009806 , A10010267 , A10010524 , A10005340 , A10005692 , A10006015 , A10006491 , A10007008 , A10007508 , A10008039 , A10008636 , A10009493 , A10009807 , A10010268 , A10010525 , A10005341 , A10005693 , A10006016 , A10006492 , A10007021 , A10007509 , A10008040 , A10008637 , A10009494 , A10009808 , A10010269 , A10010526 , A10005342 , A10005697 , A10006017 , A10006493 , A10007022 , A10007510 , A10008041 , A10008638 , A10009495 , A10009809 , A10010270 , A10010527 , A10005343 , A10005699 , A10006018 , A10006494 , A10007023 , A10007511 , A10008042 , A10008639 , A10009498 , A10009810 , A10010271 , A10010533 , A10005344 , A10005701 , A10006019 , A10006495 , A10007024 , A10007512 , A10008043 , A10008640 , A10009502 , A10009811 , A10010272 , A10010534 , A10005345 , A10005702 , A10006020 , A10006496 , A10007025 , A10007513 , A10008049 , A10008641 , A10009503 , A10009812 , A10010273 , A10010535 , A10005346 , A10005703 , A10006021 , A10006497 , A10007031 , A10007514 , A10008050 , A10008642 , A10009504 , A10009813 , A10010274 , A10010536 , A10005347 , A10005704 , A10006022 , A10006498 , A10007032 , A10007515 , A10008051 , A10008643 , A10009505 , A10009814 , A10010275 , A10010537 , A10005348 , A10005706 , A10006023 , A10006499 , A10007033 , A10007516 , A10008052 , A10008644 , A10009506 , A10009815 , A10010276 , A10010538 , A10005349 , A10005707 , A10006024 , A10006501 , A10007035 , A10007517 , A10008053 , A10008645 , A10009507 , A10009816 , A10010277 , A10010539 , A10005350 , A10005708 , A10006025 , A10006502 , A10007035 , A10007518 , A10008079 , A10008646 , A10009508 , A10009817 , A10010278 , A10010540 , A10005351 , A10005709 , A10006026 , A10006503 , A10007036 , A10007519 , A10008080 , A10008647 , A10009509 , A10009824 , A10010279 , A10010541 , A10005352 , A10005711 , A10006027 , A10006504 , A10007036 , A10007520 , A10008081 , A10008648 , A10009510 , A10009825 , A10010280 , A10010542 , A10005355 , A10005713 , A10006028 , A10006505 , A10007037 , A10007521 , A10008082 , A10008649 , A10009511 , A10009826 , A10010281 , A10010548 , A10005356 , A10005714 , A10006029 , A10006506 , A10007037 , A10007522 , A10008083 , A10008650 , A10009522 , A10009827 , A10010282 , A10010549 , A10005357 , A10005715 , A10006030 , A10006507 , A10007038 , A10007523 , A10008084 , A10008651 , A10009523 , A10009828 , A10010283 , A10010550 , A10005358 , A10005718 , A10006031 , A10006508 , A10007038 , A10007524 , A10008085 , A10008655 , A10009524 , A10009829 , A10010284 , A10010551 , A10005359 , A10005723 , A10006032 , A10006509 , A10007039 , A10007526 , A10008086 , A10008658 , A10009525 , A10009830 , A10010285 , A10010552 , A10005360 , A10005724 , A10006033 , A10006510 , A10007039 , A10007527 , A10008087 , A10008659 , A10009526 , A10009831 , A10010286 , A10010553 , A10005361 , A10005725 , A10006034 , A10006511 , A10007040 , A10007528 , A10008088 , A10008793 , A10009527 , A10009832 , A10010287 , A10010554 , A10005362 , A10005726 , A10006035 , A10006512 , A10007040 , A10007529 , A10008094 , A10009173 , A10009528 , A10009864 , A10010288 , A10010555 , A10005363 , A10005727 , A10006036 , A10006513 , A10007041 , A10007530 , A10008095 , A10009174 , A10009529 , A10009865 , A10010289 , A10010556 , A10005364 , A10005728 , A10006037 , A10006514 , A10007041 , A10007531 , A10008096 , A10009175 , A10009530 , A10009866 , A10010290 , A10010557 , A10005365 , A10005733 , A10006038 , A10006515 , A10007042 , A10007532 , A10008097 , A10009176 , A10009531 , A10009867 , A10010291 , and A10010563. |
Recalling Firm/ Manufacturer |
Neuronetics, Inc. One Great Valley Parkway Suite 2 Malvern PA 19355
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For Additional Information Contact | Judy P. Ways, Ph.D. 610-640-4202 Ext. 1006 |
Manufacturer Reason for Recall | SenStar Treatment Link may have an open circuit that during use with the NeuroStar TMS Therapy system may cause arcing and heat damage to the SenStar and/or treatment coil. Heating of the SenStar during use has a potential risk of minor scalp burn to patients. |
FDA Determined Cause 2 | Process control |
Action | Neuronetics Inc. notified consignees by telephone and sent a follow-up fax/letter dated March 19, 2009 titled "Urgent Product Recall Notification." The letter describes the issue and actions for consumers to take in response to the recall. Neuronetics will visit each customer in person to complete a "Returned Goods: SenStar Recall Inventory Form."
Customer questions should be directed to Neuronetics Customer Service at 1-877-600-7555. |
Quantity in Commerce | 3123 Units |
Distribution | Nationwide Distribution to AZ, CA, DC, GA, FL, IL, MD, MI, MN, NH, NY, PA, RI, SC, and WA. |
Total Product Life Cycle | TPLC Device Report |
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = OBP
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