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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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Product Detail

Product Description Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic imaging
Recall Number Z-0120-2014
Classification Class II
Code Info 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
Product Distributed Qty 477 (1352 total)
Reason For Recall 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.

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
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