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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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Event Detail

Event ID 66059
Product Type Devices
Status Ongoing
Recalling Firm Toshiba American Medical Systems Inc
City Tustin
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-05
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide Distribution including and US Territory Puerto Rico

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging Lot Numbers not utilized. Serial Numbers: LGA0792628 LGA0792564 LGA0792565 LGA0792531 LGA0792540 LGA0792541 LGA0792617 LGA0792554 LGA0792626 LGA0792627 LGA0792552 LGA0792616 LGA0792563 LGA0792553 LGA0792615 LGA0792551 LGA0792613 Class II The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly cause the patient to be burned during the procedure:1. The system is set to 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode, and 2) "IQBalance BD" or "IQ Balance" BCD" is displayed on the touch panel as a result of scale setting for PW mode. 17 (1352 Total) Z-0119-2014
Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic imaging Lot Numbers not utilized. Serial Numbers: 99A07Y2151 99E0993437 99K1285044 99F1033857 99F1033858 99F1033859 99K11Z4906 99K11Z4907 99J1114445 99G1094194 99H10X4240 99E0973301 99G1074050 99G1074051 99G1074052 99E0973302 99J1114443 99G1084118 99D0892684 99K1184804 99D08Y2744 99K1285039 99K11Z4917 99E0963141 99E0963157 99E0963158 99E0963168 99D0892680 99D0892687 99D08Z2840 99D0953122 99E0973308 99E09X3463 99F09Z3684 99D08Z2829 99E0993408 99K1285041 99D0892692 99A07Y2109 99E0993414 99E0993415 99K1214940 99E0983369 99D0892688 99D0892689 99D0892691 99D0892693 99C0872552 99C0872568 99A07Y2097 99A07Y2098 99B07Z2248 99E0993436 99E0993445 99K1234985 99D0953125 99K1184805 99K1285046 99K12X5050 99K12X5051 99K12X5052 99K12X5053 99D0912881 99D08Y2762 99D0922958 99D0922959 99D0922960 99H10X4236 99K12Y5055 99K11Z4928 99F09Z3691 99C0872564 99F1043913 99K1244991 99A07Y2086 99E0973304 99G1053958 99J1134603 99E0983371 99A07Y2100 99B07Z2242 99B07Z2251 99F09Z3664 99D0943018 99E09X3467 99D08Y2759 99D08Y2760 99C0872551 99A07Y2089 99D0922957 99H10X4242 99D0953102 99A07Y2092 99A07Y2106 99A07Y2157 99B07Z2233 99B07Z2258 99C0882610 99C0882611 99D0943045 99D0943047 99E0983370 99F1013749 99F1033860 99F1043912 99G1053954 99G1053956 99K11Z4904 99K1285040 99A07Y2094 99H10X4237 99D08Z2826 99G1053962 99F09Z3663 99K11Z4905 99E09X3450 99C0872566 99A07Y2104 99F1013734 99B07Z2260 99A07Y2083 99D0953124 99D0892681 99J1114444 99E0993446 99J1124539 99J1134600 99A07Y2108 99K11Z4929 99A07Y2085 99F1043911 99E09X3462 99C0882619 99D08Y2747 99C0882607 99C0882608 99F1013743 99A07Y2091 99E0993447 99E0993448 99E0973310 99E0983362 99A07Y2159 99A07Y2158 99B07Z2252 99E09X3504 99J1144668 99J1124540 99J1134601 99G1053951 99H10X4239 99I10Z4387 99I10Z4388 99D0922954 99K1164753 99K1265026 99B07Z2249 99H10X4235 99K1194857 99K11X4876 99D0912880 99F1013735 99K11X4864 99G1084120 99G1084121 99G1094181 99G1094182 99G1094183 99K11Z4922 99G1053960 99F1013737 99E0983372 99E0983373 99F09Z3668 99G1064005 99D0943049 99K1285038 99D0892690 99E09X3461 99D0943048 99D0912884 99E0993416 99E09X3460 99G1094184 99A07Y2081 99K11X4870 99B0832365 99B07Z2261 99E09X3458 99E09X3459 99D08Z2838 99D0932997 99D0892682 99D0912879 99G1053961 99G1084117 99D0943020 99I10Z4389 99B0812292 99B0812293 99J1114447 99G1063999 99G1064001 99G1053953 99J1124538 99K12Y5056 99G1094191 99F09Z3685 99D0932999 99F09Z3688 99F09Z3662 99D0953100 99K11Z4916 99D0922953 99E0963177 99E0973303 99E0963169 99F09Z3667 99F09Z3689 99B07Z2243 99E09X3505 99B07Z2254 99E09X3497 99B07Z2259 99D0953126 99B0832368 99E0993434 99E0993435 99A07Y2082 99B0812294 99F09Z3690 99F09Z3660 99F09Z3661 99K12X5054 99H10X4241 99A07Y2090 99F09Z3687 99K1194858 99F09Z3686 99D0912887 99F1013756 99D0912894 99G1094193 99K1164755 99D0912885 99F09Z3669 99F09Z3670 99C0882620 99C0882614 99K1164754 99E09X3451 99I10Z4391 99B0812295 99C0872565 99G1074048 99K1184801 99C0872567 99E0993444 99D08Z2836 99D08Y2746 99D0912896 99A07Y2107 99B07Z2241 99D08Y2745 99A07Y2080 99D0892685 99J1144667 99B07Z2244 99B07Z2245 99B07Z2246 99J1134602 99K11X4872 99K11X4874 99K11X4875 99K11Y4885 99K11Y4886 99A07Y2084 99B07Z2253 99D0912897 99G1074047 99K1214944 99A07Y2102 99A07Y2155 99K11X4863 99K11Z4923 99K1285045 99D0943019 99D0933004 99D0912877 99E0963143 99K1275036 99F09Z3659 99K11Z4925 99E0993412 99A07Y2087 99E0993411 99E0993413 99E0973306 99E0973307 99D0932998 99D08Z2839 99J1124537 99D0953101 99J1144669 99A07Y2103 99B07Z2231 99A07Y2105 99A07Y2152 99C0872550 99C0882606 99D0912895 99F1033856 99E09X3495 99E09X3496 99F09Z3657 99J1124533 99K1214942 99D0892694 99D08Y2758 99D0922961 99E0993407 99D0953094 99J1114448 99E0973309 99A07Y2101 99K1244990 99E09X3465 99C0882618 99F1013750 99F1013755 99J1144650 99K1244993 99A07Y2156 99A07Y2099 99F1013736 99A07Y2093 99K11Z4919 99K11Z4920 99G1053957 99D08Z2837 99C0882617 99D0922962 99D0932995 99E0963176 99B0812291 99K1265027 99F1013744 99F1013745 99J1144648 99B0832366 99D0933003 99E0993410 99K11X4871 99I10Z4390 99K1184802 99K1184803 99B07Z2256 99B07Z2257 99B0812299 99E09X3507 99E09X3508 99E09X3509 99E09X3510 99B07Z2232 99E0963144 99D0912886 99G1084119 99B07Z2255 99K1285042 99C0872549 99F09Z3658 99D0953103 99D0932996 99K1164751 99F1013748 99J1144649 99D0953123 99C0882615 99C0882616 99E0963170 99E0963171 99E0963172 99E0963173 99F09Z3665 99F09Z3692 99F1013738 99F1013742 99E0963154 99E0983359 99F1043914 99F1043915 99F1013741 99E0983360 99E0983361 99F09Z3683 99D0922947 99K1214939 99H10X4233 99H10X4234 99K11Z4903 99K1275037 99K1234986 99K1234987 99K11Z4926 99B07Z2230 99D0892686 99B07Z2247 99K1244992 99F1013746 99F1013747 99E0993438 99E0993442 99K1194859 99K11Z4927 99D08Y2743 99E0983358 99C0882612 99C0882613 99E0993443 99E0973300 99G1094192 99D08Z2830 99F1013758 99E0963142 99K1214943 99K11Z4918 99B0812296 99B0812297 99B0812298 99D0922946 99E0963156 99D0943046 99H10X4238 99A07Y2095 99D08Z2827 99C0882609 99A07Y2096 99A07Y2153 99E09X3466 99K1275035 99F09Z3671 99J1144671 99F09Z3666 99D08Z2828 99G1064002 99G1064004 99E0993409 99E0963140 99E0963155 99F1013757 99E0963174 99E0963175 99E09X3464 99D0892683 99J1144670 99B07Z2240 99B07Z2234 99E09X3449 99K1285043 99E09X3473 99E09X3474 99E09X3475 99B0812300 99E09X3506 99B0832367 99B0832369 99C0872553 99D0912883 99A07Y2154 99J1134604 99J1144646 99J1144647 99A07Y2088 99D0922955 99K1244989 99G1053952 99K11Z4924 Class II The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly cause the patient to be burned during the procedure:1. The system is set to 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode, and 2) "IQBalance BD" or "IQ Balance" BCD" is displayed on the touch panel as a result of scale setting for PW mode. 477 (1352 total) Z-0120-2014
Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging Lot Numbers not utilized. Serial Numbers: A1G1194387 A1E10Z3293 A1E10Z3294 99A09Y2120 99B09Z2178 99B09Z2179 A1F1143915 A1G1194385 A1G1194394 A1G1194395 A1G1194396 A1E10Z3339 A1E10Z3340 A1E10Z3341 A1G11Z4565 99B09Z2174 A1G1174188 A1G1194355 A1G1194356 A1G1184257 A1G1184258 A1G1194392 A1G1194406 99B1022343 A1F1113439 A1F1133733 A1F1133846 A1C1072756 A1C1072763 A1C1082867 99A09X2090 99A09X2092 A1C1093010 A1G1214637 A1G11Z4566 A1E10Z3295 A1E10Z3308 A1E10Z3312 A1G1194397 A1E10Z3311 A1F1123626 A1F1123633 A1C1082816 A1C1082830 A1C1082837 A1C1082838 A1C1082842 A1C1082843 A1C1082847 A1G1194373 A1F1123624 A1G1194393 A1F1133840 99B1032438 A1F1113440 A1F1113443 A1F1113444 A1F1133863 A1F1123693 A1F1133760 A1F1133772 A1F1133773 A1C1092961 A1C1092970 A1B1062657 A1E10Z3296 A1G11Z4575 A1F1133740 A1F1133780 A1C1093018 A1G1194384 A1F1133776 A1G1184302 A1G1184303 A1G1194364 A1G1194371 A1G1194372 A1C1082874 A1B1062687 A1C1082868 A1C1082873 A1C1082851 A1C1082862 A1C1082856 A1C1082884 A1G1214636 A1C1082861 A1C1082879 A1C1082880 A1C1082885 A1G1184256 A1G1194401 A1E10Z3359 A1E10Z3360 A1E10Z3361 A1E10Z3369 A1E10Z3370 A1E10Z3371 A1F1123625 A1F1113455 A1A1042483 A1B1052583 A1C1072774 A1C1072782 99B1022344 99B1022347 A1A1042474 A1A1042477 A1A1042480 A1A1042496 99B1032444 A1C1092929 99A09X2087 99A09X2091 99A09Y2114 A1G11Z4568 A1F1133737 A1G1194383 99B1032416 99B09Z2173 99B09Z2182 A1G1184276 A1E10Z3306 A1E10Z3307 A1F1123614 A1B1062646 A1B1062651 A1G1194379 A1E10Z3326 99B09Z2180 99B09Z2181 A1G11Z4567 A1F1123665 99B09Z2171 A1B1062664 A1B1062665 99B1032437 A1F1143918 A1E10Z3356 A1G1194398 99A09Y2116 99B1012242 A1F1123679 A1G1194377 A1C1092920 99B1012227 A1F1133875 99A09X2094 A1A1042491 A1A1042501 A1B1052571 A1F1113466 99B1022345 99B1022346 A1B1062656 A1B1062691 A1B1062696 A1F1133862 A1A1042513 A1B1052569 A1G1184296 99B1012243 A1F1143887 A1B1062634 A1F1133763 A1F1123692 A1E10Z3357 99B1022351 A1G1184289 A1G1184295 A1G1194403 A1F1133762 99B1032447 99A09X2095 99A09Y2113 A1F1143927 A1F1113442 A1F1133764 A1C1072754 A1C1072755 A1C1082823 A1C1072764 A1C1072765 A1C1072773 A1F1113445 A1F1113446 A1F1133789 A1B1052590 A1E10Z3347 A1E10Z3348 A1E10Z3352 A1E10Z3354 A1G1194399 A1B1062660 A1F1143926 A1C1093009 A1G1194376 A1F1113438 A1B1062675 A1G11Z4592 99B1012226 A1G1184254 A1F1143897 A1E10Z3372 A1E10Z3373 99B1032424 A1F1133795 A1F1133819 99B09Z2185 99B1022348 99B1022349 A1F1143891 A1F1143892 A1G1174186 A1B1052572 A1B1062674 A1F1143885 A1G1194381 A1G1194380 A1G1184277 A1G1184282 A1F1143907 99B1012240 99A09X2086 99B09Z2170 A1B1062628 A1F1133734 99B1022337 99B1022338 99B1022339 99B1022340 A1F1133785 A1G11Z4595 A1F1133786 A1F1133793 A1F1133735 A1F1133747 A1F1133748 99A09Y2119 A1G11Z4564 99A09Y2117 A1F1133848 A1B1052573 A1C1092953 A1G1174189 A1G1194359 A1G1194360 A1G1194361 A1G1194362 A1B1062661 A1A1042487 A1G1244755 A1F1123666 A1F1123667 A1F1113458 A1F1113441 A1F1133774 A1C1092937 A1F1143877 A1G1214639 A1C1072783 A1F1133787 A1F1133788 A1F1133790 99B1012236 99B1012237 99B1012238 99B1012228 99B1012229 A1G1194357 A1F1123634 A1F1123643 A1F1133791 A1F1133838 A1F1133860 A1F1133844 A1F1133847 A1F1113447 A1F1113454 A1E10Z3342 A1E10Z3346 A1E10Z3353 A1G1194405 A1F1113467 A1G1194404 A1C1092921 99B1032433 A1G1194400 99B1032434 99B1032435 A1G1174190 A1G1194358 A1B1062669 99B1032425 99B09Z2172 A1F1133738 A1F1113468 A1E10Z3335 A1F1123615 A1F1113456 A1F1113457 A1F1143898 A1C1092928 A1C1092960 A1F1133845 A1B1052597 A1B1052604 99B1012225 99B1032446 A1F1123680 A1B1062679 A1G1184253 A1G1214638 A1E10Z3292 A1E10Z3305 A1G1184259 A1F1133781 A1F1133782 A1F1133783 A1F1133784 A1E10Z3299 A1E10Z3300 A1E10Z3313 A1E10Z3314 A1E10Z3321 A1E10Z3322 A1E10Z3325 99B1032436 99B1032445 99B1032448 A1E10Z3355 A1C1093016 A1G1174187 99B1022341 99B1022342 A1G1194402 99B1032429 99B1032432 A1F1123644 99B1032430 99B1032431 A1F1123645 A1G11Z4577 A1G11Z4578 A1G11Z4579 A1G11Z4591 99B09Z2186 99B09Z2187 99B09Z2188 99B09Z2189 99B1012235 A1C1092936 A1E10Z3319 A1E10Z3320 A1E10Z3327 A1E10Z3328 A1E10Z3332 A1E10Z3333 A1E10Z3334 A1G1194382 A1G1194363 A1G11Z4593 A1F1133876 A1G11Z4576 99B1032418 99B1032419 99B1032420 A1B1052576 99B1012244 A1B1062640 A1F1143893 A1F1143894 A1F1143895 A1F1143902 99B1012241 A1B1062683 A1F1113470 A1F1133821 A1F1133820 A1F1133859 A1F1143884 A1F1143889 A1G1184255 A1F1113469 A1G1194386 A1B1062670 A1F1123695 A1F1123696 A1A1042507 A1C1092971 A1C1092980 A1C1092989 A1C1092999 99B1032428 A1F1133839 A1F1133775 A1G1214635 A1F1123694 A1G1244751 A1G1244752 A1G1244753 A1G1244754 A1F1143888 A1F1133761 A1F1133794 A1G1184283 A1G1184288 A1G11Z4594 A1F1133822 A1F1133823 A1F1133836 A1G1194378 99B1022350 99A09X2089 A1F1133861 A1C1092944 A1C1092945 A1C1092952 A1F1143886 99B1012239 99A09Y2118 A1F1143922 A1F1133739 99A09X2093 A1F1133837 A1C1093017 99B1032417 Class II The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly cause the patient to be burned during the procedure:1. The system is set to 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode, and 2) "IQBalance BD" or "IQ Balance" BCD" is displayed on the touch panel as a result of scale setting for PW mode. 427 units (1352 total) Z-0121-2014
Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging Lot Numbers not utilized. Serial Numbers: 99D0833447 99E0873714 99G0995029 99D0823343 99F0924404 99G09Y5216 99E0863552 99E0863553 99G0964771 99C0792920 99F0893870 99B06Z2073 99C07X2964 99C0792918 99B06Z2063 99C0792919 99G0964712 99G0964713 99G0974899 99F0944563 99D0823349 99G0995131 99G0995132 99G0995133 99G0995134 99G09Y5224 99C0792914 99D0813229 99D0813230 99D0813231 99E0873711 99E0873716 99E0873717 99B06Z2072 99B0752508 99B0752509 99B0752510 99B0752511 99C0792915 99C0792937 99F0893967 99F08Y4079 99F08Y4085 99F08Y4086 99F0924389 99F0924395 99F0924405 99B06Z2107 99G1045683 99C07Y3068 99C07Y3069 99B0782760 99C07Y3047 99B0722268 99B0722269 99B0722270 99B0722271 99B0722272 99B0732349 99B0732350 99B0732351 99B0732352 99B0732353 99B0732354 99E0863691 99E0863692 99G0995139 99B0722208 99B0722250 99F0934520 99C0782863 99B06Z2061 99G0995071 99G09Y5260 99G09Y5261 99D0813225 99D0813226 99E0863586 99E0863587 99C0782860 99G0964777 99B0752531 99D07Z3138 99D0813224 99B0752532 99D07Z3139 99B06Z2088 99B0722251 99C07X2965 99F0914260 99F0914261 99F0914269 99G09Z5369 99G09Y5256 99F08Y4078 99D0833438 99G09Z5367 99F0893846 99E0873713 99B06Z2071 99C0782864 99C07Y3061 99D0833437 99G0974883 99G0974884 99F0893855 99F0893854 99B0782767 99B0782786 99F0914266 99G1015473 99G09Z5370 99G09Z5374 99G09Z5375 99G1015474 99B06Z2109 99B06Z2068 99B06Z2060 99C0792930 99D0823363 99D0833441 99D0823364 99D0823365 99D0833440 99G09Y5264 99B0722206 99B0722207 99B0722204 99B0752524 99B0752525 99F0914265 99F0914289 99E0873720 99G09Y5257 99F0893866 99F0893969 99D0823351 99B0732355 99B0742413 99B0742414 99G0995135 99D0823342 99E0863572 99D0833450 99E0863549 99E0863550 99E0873712 99E0863570 99E0863571 99B06Z2055 99D0833451 99B0742415 99B0742416 99B0742417 99G09Y5223 99F0914263 99B0722203 99B0782788 99C0782866 99B06Z2062 99F0934528 99B0782766 99B0722201 99F0893961 99F0934532 99G09Z5379 99G1015468 99F0924394 99G1015472 99G09Y5262 99G09Y5263 99B0722252 99G0974886 99F0893868 99F0893869 99G0964772 99F0944536 99F0893851 99F0934527 99G09Y5258 99B0752548 99G1045682 99L1166369 99B06Z2090 99G1015471 99F0893850 99G09Z5382 99G09Z5383 99G0964775 99G0964776 99B06Z2105 99B06Z2110 99F0924392 99C07X2968 99F0944537 99F0944538 99B06Z2070 99C07Y3050 99C07Y3051 99B06Z2058 99B0782789 99G0964715 99D0823346 99D0823347 99D0823348 99G0974887 99G0974897 99G0974898 99F0893848 99G0995027 99D07Z3132 99E0863585 99E0863702 99F0893847 99F0893970 99F0944564 99G09Z5380 99B06Z2114 99B0722254 99C07Y3063 99F0893966 99F0914267 99D0833448 99D0833449 99E0863706 99E0863707 99F0893849 99B0752507 99G0964774 99F0893867 99G0984982 99G0995026 99E0863588 99G0995137 99G0995138 99G09Y5219 99G09Y5220 99F0924396 99F0924397 99B0712171 99B06Z2104 99B0712169 99G0984979 99G1015465 99B0712172 99E0863568 99B0722202 99B0752570 99C07Y3043 99C07Y3044 99C07Y3045 99C07Y3062 99C07Y3064 99C07Y3065 99G0974900 99C0782861 99C07X2967 99F0944566 99B06Z2069 99B0752562 99B0752563 99B0752564 99B0752565 99D0833452 99G1015466 99F0893965 99F0944535 99E0873718 99B06Z2103 99F0934530 99E0873719 99G09Z5377 99G09Z5378 99C0792935 99C0792936 99D0813227 99D0823350 99G0995136 99G09Z5376 99B06Z2056 99B06Z2075 99E0873715 99F0924391 99F0924403 99B0782769 99F0914288 99B0752523 99B06Z2064 99B0712170 99B0752551 99B06Z2113 99E0863584 99F0893852 99F0893853 99G0964711 99G0995072 99F0924393 99B0782768 99G09Z5384 99G09Z5385 99B0752550 99E0863569 99C0782859 99B06Z2092 99G1015476 99G09Y5221 99G09Y5215 99E0863693 99E0863694 99E0863695 99E0863696 99E0863697 99E0863698 99C0792912 99B06Z2066 99G0984981 99C0792917 99D0823345 99F0914290 99F0914291 99F0914292 99F0924401 99G09Z5371 99G09Z5372 99G09Z5373 99L1166370 99F0893968 99E0863551 99F0893962 99F08Y4080 99F0914259 99G0984978 99F08Y4082 99F08Y4083 99F08Y4084 99F0934519 99F0893964 99F0934533 99D0833442 99F08Y4077 99B06Z2074 99F0914262 99F0934529 99G09Y5222 99B06Z2116 99B0782764 99B0782765 99E0863699 99B0712173 99B0712174 99G0984980 99B0782759 99E0863705 99C07Y3046 99D0813228 99B0752561 99C07Y3048 99B06Y2048 99B06Z2057 99B06Z2108 99C07X2966 99G0974885 99G1015470 99B06Y2051 99B06Z2115 99F0934526 99B0782763 99D0833436 99D0813233 99G1015475 99G09Y5259 99C0792916 99G0995028 99C0792931 99B06Y2050 99B06Z2112 99G0974896 99D0833443 99F0944539 99B06Z2102 99C0782862 99C0792913 99C07X2963 99G09Z5368 99B0752549 99G09Y5217 99G09Y5218 99E0863688 99G0964769 99G0964770 99C07X2969 99G0964773 99F08Y4081 99C0792934 99F0914268 99C0792933 99D07Z3134 99E0863689 99D0823344 99D07Z3133 99B0712168 99G0964714 99C07Y3052 99C07Y3049 99D0833444 99D0833445 99B0782787 99C0782858 99D0833453 99B0722205 99B06Z2091 99G1015467 99B0752547 99E0863690 99G0964778 99F0934531 99B06Z2106 99E0863701 99D0833439 99D0813232 99E0863704 99B06Y2049 99B06Z2067 99F0924402 99G0995140 99B0722253 99F0944565 99G09Y5265 99G09Z5364 99G09Z5365 99G09Z5366 Class II The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly cause the patient to be burned during the procedure:1. The system is set to 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode, and 2) "IQBalance BD" or "IQ Balance" BCD" is displayed on the touch panel as a result of scale setting for PW mode. 430 (1352 total) Z-0122-2014
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