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U.S. Department of Health and Human Services

Class 2 Device Recall Aplio MX Diagnostic Ultrasound System SSA780A

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  Class 2 Device Recall Aplio MX Diagnostic Ultrasound System SSA780A see related information
Date Initiated by Firm August 05, 2013
Date Posted October 30, 2013
Recall Status1 Terminated 3 on June 28, 2016
Recall Number Z-0121-2014
Recall Event ID 66059
510(K)Number K092948  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product Aplio MX Diagnostic Ultrasound System SSA-780A

Used for routine diagnostic imaging
Code Information 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 
Recalling Firm/
Manufacturer		 Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin CA 92780-7047
For Additional Information Contact
714-730-5000
Manufacturer 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
FDA Determined
Cause 2		 Device Design
Action Toshiba sent an Urgent Medical Device Correction letter dated August 5, 2013. along with a Reply Form via USPS return receipt mail. The letter identified the product, the problem, and the action to be taken by the customer. Until the software is corrected customers were instructed to change the preset settings as described in the letter. Customers were asked to complete and return the attached form and fax it to the toll free number. The form also can be sent via email to raffairs@tams.com Customers with questions were instructed to call 800-421-1968 or contact their local Toshiba Representative at 800-521-1968. For questions regarding this recall call 714-730-5000.
Quantity in Commerce 427 units (1352 total)
Distribution Nationwide Distribution including and US Territory Puerto Rico
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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