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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 Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging
Recall Number Z-0122-2014
Classification Class II
Code Info 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
Product Distributed Qty 430 (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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