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U.S. Department of Health and Human Services

Class 2 Device Recall GE Voluson E8 Ultrasound System

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 Class 2 Recall
GE Voluson E8 Ultrasound System
see related information
Date Posted September 22, 2008
Recall Status1 Open
Recall Number Z-2404-2008
Recall Event ID 49068
Premarket Notification
510(K) Number
K061682 
Product Classification System, Imaging, Pulsed Echo, Ultrasonic - Product Code IYO
Product GE Voluson® E8 Ultrasound System with software versions 6.0.0, 6.0.1,6.1.0, 6.2.0, 6.2.1, 6.2.2, 6.2,3, 7.0.0, and 7.01. Intended for use by a qualified physician for ultrasound evaluation of Fetal?OB; abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal (TV); Transrectal (TR); and Intraoperative (abdominal , PV neurological).
Code Information Sno D00854 D03101 D03423 D00152 D00289 D00323 D00408 D00414 D00477 D00482 D00676 D00679 D00838 D00866 D03109 D03172 D03401 D03422 D03441 D03626 D03849 D03855 D03119 D03683 D03866 D00160 D00212 D00283 D00320 D00377 D00427 D00463 D00678 D01032 D01038 D03206 D03287 D03358 D03391 D03498 D03625 D00811 D00832 D03154 D00578 D03492 D03617 D03644 D03677 D03743 D03295 D00161 D00329 D00370 D00371 D00472 D00588 D00589 D00921 D00229 D00164 D00664 D00979 D00998 D01001 D03216 D03655 D00181 D00191 D00269 D00390 D00709 D00717 D00786 D00805 D00882 D00883 D00885 D00886 D00891 D01021 D00857 D03478 D00123 D00530 D00942 D00947 D00948 D01066 D03400 D03427 D03442 D03704 D03183 D03864 D00361 D00737 D03384 D03712 D00738 D00144 D03440 D03233 D03488 D00620 D00895 D00985 D03643 D00211 D00743 D03196 D03342 D03402 D03654 D03742 D03765 D03776 D03779 D03780 D03845 D00724 D00731 D03507 D03490 D03493 D03494 D03495 D00363 D00368 D03382 D00515 D00131 D00309 D00334 D00429 D00874 D03581 D00699 D03628 D00146 D00179 D00202 D00208 D00215 D00221 D00237 D00257 D00260 D00263 D00265 D00268 D00271 D00285 D00286 D00353 D00358 D00439 D00458 D00479 D00489 D00511 D00518 D00538 D00598 D00600 D00605 D00621 D00648 D00660 D00661 D00673 D00675 D00708 D00714 D00732 D00845 D00848 D00865 D00896 D00909 D00937 D00944 D00945 D00961 D01010 D01011 D01062 D03110 D03111 D03138 D03148 D03159 D03173 D03207 D03267 D03269 D03280 D03296 D03310 D03322 D03327 D03331 D03332 D03333 D03336 D03343 D03351 D03352 D03354 D03355 D03362 D03364 D03365 D03367 D03368 D03369 D03374 D03375 D03376 D03379 D03381 D03418 D03424 D03456 D03491 D03523 D03532 D03533 D03540 D03545 D03550 D03577 D03597 D03598 D03600 D03601 D03602 D03603 D03604 D03605 D03606 D03607 D03610 D03612 D03614 D03615 D03616 D03664 D03665 D03672 D03673 D03675 D03678 D03682 D03684 D03706 D03720 D03721 D03722 D03726 D03732 D03761 D03763 D03816 D03833 D03843 D00145 D00196 D00201 D00204 D00205 D00206 D00207 D00216 D00219 D00274 D00275 D00276 D00281 D00287 D00410 D00438 D00447 D00496 D00527 D00596 D00610 D00674 D00842 D00899 D00967 D01045 D03102 D03113 D03117 D03131 D03285 D03301 D03313 D03325 D03326 D03328 D03348 D03360 D03366 D03371 D03378 D03431 D03474 D03536 D03585 D03595 D03666 D03667 D03671 D03676 D03679 D03681 D03783 D00117 D00121 D00138 D00141 D00150 D00165 D00167 D00170 D00171 D00183 D00218 D00253 D00256 D00259 D00261 D00267 D00273 D00311 D00313 D00315 D00328 D00378 D00383 D00385 D00431 D00441 D00448 D00461 D00606 D00607 D00614 D00615 D00617 D00618 D00623 D00681 D00716 D00830 D00860 D00861 D00862 D00867 D00871 D00872 D00873 D00901 D00935 D00955 D00988 D03118 D03120 D03132 D03161 D03175 D03176 D03189 D03194 D03270 D03361 D03388 D03389 D03390 D03404 D03405 D03408 D03413 D03414 D03420 D03425 D03428 D03429 D03430 D03483 D03512 D03515 D03522 D03525 D03530 D03565 D03583 D03586 D03591 D03592 D03596 D03629 D03641 D03642 D03647 D03649 D03740 D03769 D00154 D00177 D00190 D00234 D00235 D00245 D00247 D00262 D00264 D00443 D00457 D00462 D00536 D00612 D00613 D00650 D00667 D00869 D00870 D00914 D00930 D00984 D00994 D01067 D03011 D03265 D03284 D03297 D03372 D03406 D03407 D03409 D03573 D03594 D03646 D03668 D03674 D03689 D03738 D03805 D00143 D00590 D00828 D03123 D03141 D03209 D03212 D03417 D03527 D03685 D00941 D00723 D00483 D00498 D00719 D00728 D01008 D01056 D03453 D03657 D03719 D00394 D03251 D03852 D00288 D00736 D03377 D03457 D03476 D03477 D00308 D00905 D03450 D03465 D00122 D00499 D00622 D00730 D00807 D00812 D00829 D00878 D00943 D03502 D03503 D03505 D03526 D03531 D03554 D03567 D03691 D03725 D03744 D03754 D00156 D00424 D00535 D00818 D00839 D00879 D00970 D01051 D03524 D03699 D00113 D00434 D00868 D03105 D03260 D03528 D03659 D03696 D00950 D00954 D00958 D00959 D03660 D03661 D03728 D03756 D00332 D00722 D00933 D00949 D00322 D01015 D03609 D00508 D03394 D03396 D03290 D03717 D01039 D01040 D00240 D00756 D00934 D00946 D01018 D03433 D00126 D03397 D00272 D00971 D03171 D00341 D03818 D00692 D00504 D00680 D00974 D03737 D00478 D00645 D01012 D03658 D03104 D00533 D00982 D00507 D03762 D03289 D03403 D03475 D00279 D00688 D00521 D03707 D00278 D00407 D00449 D03385 D03392 D03432 D03460 D00128 D00277 D00529 D00534 D00634 D00643 D00690 D00980 D00981 D01014 D01016 D03416 D03448 D03454 D03470 D03472 D03479 D03727 D03749 D00419 D00644 D00682 D00721 D03703 D00684 D01013 D00663 D00486 D00528 D00583 D00641 D00647 D00672 D01052 D01053 D01055 D03164 D03182 D03191 D03198 D03231 D03249 D03275 D03282 D03294 D03299 D03349 D03357 D03383 D03393 D03395 D03398 D03399 D03419 D03426 D03608 D03631 D03736 D00474 D03439 D00475 D00635 D00713 D01017 D03230 D03410 D03630 D03634 D00939 D00157 D00338 D00686 D03179 D03537 D03651 D03652 D01076 D03438 D03443 D03690 D00687 D00917 D00514 D03618 D03686 D03808 D00876 D01046 D03656 D00225 D00677 D03819 D00646 D01070 D01073 D03582 D03611 D03786 D03789 D03790 D03791 D03792 D03830 D03848 D03850 D03851 D00217 D00153 D00222 D00248 D00591 D00599 D03155 D03192 D03201 D03140 D03637 D03386 D00321 D03135 D03356 D00432 D00473 D03387 D03580 D03624 D00799 D00964 D00966 D00440 D00911 D03359 D03363 D03373 D03782 D00466 D00611 D00898 D00975 D03200 D03486 D00409 D00494 D00659 D03858 D03547 D03853 D00501 D03543 D03552 D03555 D03584 D03599 D00446 D00500 D00890 D03293 D03648 D00951 D03796 D03827 D03846 D03860 D00442 D01050 D01057 D03688 D00453 D00452 D03116 D03521 D00101 D00471 D03662 D00436 D00755 D00841 D00846 D00922 D00956 D01061 D03108 D03250 D03412 D03473 D03482 D03504 D03508 D03518 D03535 D03632 D03700 D00151 D00734 D00750 D00877 D03170 D03286 D03734 D03772 D00524 D00603 D00604 D00324 D00417 D00428 D00601 D00602 D00642 D00815 D00831 D00875 D00880 D00881 D01059 D03716 D03785 D03836 D00238 D00932 D03444 D03553 D03619 D00148 D00213 D00301 D00510 D00597 D00833 D01058 D03106 D03464 D03467 D03735 D03593 D01047 D00729 D00851 D00915 D00999 D03350 D03645 D00369 D03653 D00584 D00657 D00952 D00280 D00342 D03587 D01071 D03773 D00624 D01069 D00595 D01077 D03520 D03588 D03590 D00103 D00155 D00166 D00180 D00250 D00251 D00255 D00325 D00331 D00430 D00444 D00454 D00464 D00470 D00476 D00497 D00509 D00513 D00522 D00526 D00547 D00549 D00553 D00555 D00556 D00557 D00559 D00585 D00671 D00691 D00753 D00843 D00852 D00863 D00893 D00913 D01030 D01031 D01072 D03246 D03248 D03314 D03435 D03513 D03548 D03556 D03575 D03576 D03578 D03798 D00294 D00382 D00384 D00668 D01044 D00544 D00545 D03680 D03730 D03731 D03807 D00102 D00379 D00381 D00386 D00387 D00433 D00540 D00586 D00609 D00662 D00683 D00766 D00844 D00864 D00957 D01043 D01048 D01054 D03005 D03114 D03125 D03190 D03245 D03252 D03271 D03272 D03277 D03278 D03279 D03562 D03589 D03613 D03633 D03640 D03650 D03698 D03708 D03710 D03739 D03741 D03771 D03800 D03802 D03809 D03810 D03811 D03839 D00233 D00517 D00523 D00525 D00542 D00822 D03199 D03241 D03484 D03340 D03311 D00343 D00630 D00669 D00793 D00800 D00973 D00990 D03236 D03242 D03449 D03480 D03487 D03781 D03806 D03345 D03276 D03330 D03339 D00193 D00197 D00303 D00304 D00306 D00307 D00349 D00356 D00359 D00367 D00372 D00375 D00412 D00465 D00490 D00495 D00552 D00558 D00566 D00571 D00574 D00580 D00581 D00638 D00665 D00703 D00735 D00745 D00751 D00767 D00769 D00776 D00788 D00795 D00809 D00889 D00938 D00987 D00989 D01007 D03144 D03273 D03283 D03347 D03370 D03461 D03466 D03489 D03511 D03541 D03621 D03787 D03815 D03822 D03826 D03829 D00592 D00480 D00701 D00725 D00801 D00884 D00326 D00337 D00347 D00411 D00469 D00631 D03825 D00720 D03264 D03497 D03514 D03516 D03559 D03560 D03561 D03563 D03564 D03566 D03568 D03569 D03570 D03571 D03572 D03574 D03579 D00492 D00139 D00451 D00992 D00996 D01004 D03733 D03801 D00485 D00502 D00636 D00707 D00718 D03137 D00258 D00350 D00351 D00364 D00554 D00903 D00910 D01020 D03195 D03455 D03458 D00168 D00186 D00203 D00224 D00242 D00249 D00310 D00317 D00388 D00445 D00561 D00582 D00768 D00772 D03149 D03274 D03341 D00632 D03261 D03485 D03509 D00173 D00236 D00244 D00330 D00339 D00340 D00694 D00695 D00758 D00760 D00765 D00775 D00778 D00782 D00794 D00995 D03133 D03324 D03334 D00182 D00254 D00398 D00649 D00742 D00810 D00819 D03153 D03187 D03202 D03213 D03215 D03220 D03223 D03232 D03259 D03320 D03335 D03447 D03549 D03759 D03764 D03774 D03777 D03813 D00415 D00627 D00640 D00656 D00797 D00968 D01033 D01037 D03129 D03130 D03235 D03499 D00189 D00192 D00195 D00200 D00209 D00366 D00393 D00468 D00953 D00972 D03169 D00418 D00481 D00487 D00563 D00570 D00573 D00575 D00579 D00666 D00816 D01024 D03160 D00178 D03152 D03225 D03255 D03337 D03462 D03463 D03517 D03534 D03558 D00421 D00516 D00543 D00920 D01009 D01035 D03304 D03459 D00314 D00142 D00395 D00405 D00413 D00425 D00562 D00564 D00567 D00693 D03107 D03115 D03122 D03185 D03211 D03222 D03224 D03228 D03229 D03253 D03256 D03298 D03309 D03338 D03353 D03380 D03415 D03446 D03451 D03452 D03755 D03799 D03803 D03812 D00300 D00158 D00344 D00352 D00397 D00403 D00460 D00541 D00548 D00888 D00892 D00894 D03240 D03436 D03437 D03821 D00176 D00316 D00423 D00435 D00791 D00826 D00897 D00912 D03145 D03214 D03346 D00711 D00712 D00726 D00727 D00887 D00228 D00246 D00302 D00399 D00493 D00653 D00655 D00963 D00978 D00336 D00392 D00420 D00422 D00625 D00633 D00639 D00652 D00763 D00813 D00993 D03126 D03162 D03167 D03227 D03254 D03288 D03300 D03344 D03820 D00293 D00346 D00503 D00512 D00531 D00546 D00565 D00741 D00749 D00752 D03157 D03165 D03268 D03748 D03751 D03775 D01019 D03219 D00977 D00292 D00296 D03147 D03234 D03302 D03421 D03501 D00568 D00577 D00923 D00931 D00936 D03136 D03197 D03217 D03218 D03221 D03243 D03308 D03316 D03318 D03321 D03329 D03500 D03551 D03622 D03623 D00108 D03747 D03750 D03752 D00685 D00696 D00733 D00777 D00781 D00787 D00789 D03319 D03323 D03445 D03510 D00223 D00239 D00241 D00282 D00629 D00790 D01034 D01036 D03814 D00199 D00214 D00220 D00318 D00373 D00705 D00770 D00774 D00780 D00825 D00908 D00919 D00927 D00194 D00357 D00484 D00537 D00539 D00616 D00628 D00651 D00698 D00702 D00740 D00744 D00771 D00773 D00779 D00783 D00784 D00785 D00792 D00821 D00960 D00962 D01000 D01002 D01005 D01006 D01025 D01027 D03184 D03186 D03237 D03266 D03291 D03317 D03542 D03620 D03638 D03768 D03784 D01023 D01026 D01028 D01029 D03193 D00134 D00243 D00626 D00654 D00670 D00739 D00747 D00748 D03128 D03139 D03146 D03150 D03151 D03158 D03168 D03174 D03178 D03180 D03238 D03257 D03258 D03262 D03263 D03292 D03305 D03306 D03434 D03496 D03538 D03757 D03760 D03767 D00455 D00467 D03778 D00230 D00231 D00762 D00764 D00983 D01003 D01022 D03127 D03797 D03823 D03824 D00105 D00127 D00132 D00135 D00136 D00185 D00187 D00335 D00355 D00532 D00569 D00572 D00576 D00700 D00710 D00746 D00754 D00759 D00761 D00806 D00820 D00840 D00847 D00850 D00858 D00906 D00907 D00918 D00928 D00986 D01042 D01060 D01074 D01075 D03281 D03312 D03315 D03471 D03481 D03506 D03519 D03539 D03544 D03546 D03714 D03746 D00227 D00991 D00997 D03203 D03303 D00658 D00107 D00114 D00163 D00175 D00184 D00188 D00198 D00210 D00226 D00232 D00252 D00291 D00295 D00297 D00299 D00305 D00312 D00319 D00327 D00333 D00345 D00354 D00362 D00389 D00391 D00396 D00400 D00402 D00404 D00406 D00450 D00459 D00491 D00506 D00550 D00551 D00560 D00697 D00704 D00706 D00798 D00802 D00803 D00804 D00814 D00817 D00824 D00835 D00900 D00904 D00924 D00925 D00926 D00929 D00969 D03103 D03134 D03142 D03156 D03163 D03166 D03177 D03188 D03205 D03208 D03210 D03226 D03411 D03529 D03557 D03627 D03635 D03636 D03639 D03663 D03669 D03670 D03687 D03693 D03694 D03697 D03701 D03705 D03709 D03711 D03713 D03718 D03723 D03729 D03745 D03753 D03758 D03766 D03770 D03788 D03817 D00855 D01041 D00426 D00519 D00593 D00856 D00859 D03468 D03469, and D03869
Recalling Firm/
Manufacturer
GE Healthcare
Manufacturer Reason
for Recall
Inaccurate dimension measurements in M-Mode when pan-Zoom is activated in GE Voluson¿ E8 Ultrasound Systems. Of particular concern are potential inaccuracies of fetal cardiac measurements that may impact patient safety.
FDA Determined
Cause 2
DESIGN: Software Design
Action Consignees were sent a GE "Urgent Medical device Correction" letter dated April 1, 22008. The letter was addressed to Healthcare Administrator/Risk Manger; Chief of Intensive Care and Director of Clinical Engineering. The letter described the safety issue; affected product details; safety instructions stating that use of the system may be continued and measurements may be made safely in M-Mode by using HD-Zoom rather than pan-Zoom; product correction stating that a GE Healthcare Rep will contact consignees in the future to schedule software updates to resolve the issue at no charge; and contact information.
Quantity in Commerce 1637
Distribution Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV,NY, OH, OK, OR, PA, RI, SC, SC, TN, TX, UT, VA, VT,WA, WI, WV, WY, and PUERTO RICO, and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LATVIA, MALAYSIA, MALTA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PARAGUAY, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, and VENEZUELA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYO and Original Applicant = GENERAL ELECTRIC CO.
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