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U.S. Department of Health and Human Services

Class 2 Device Recall 8V3c transducer

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 Class 2 Recall
8V3c transducer
see related information
Date Posted April 08, 2011
Recall Status1 Terminated on October 04, 2011
Recall Number Z-1907-2011
Recall Event ID 58006
Premarket Notification
510(K) Number
K102017 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product 8V3c transducer used with the ACUSON SC2000 ultrasound system. 8V3c transducer model number 10433823; ACUSON SC2000 model number 10433816. Siemens Medical Solutions USA, Inc. Business Unit Ultrasound 1230 Shorebird Way, Mountain View, CA 94043 High-density array transducer for pediatric and fetal echocardiography applications.
Code Information Serial numbers: 400021 400022 400024 400026 400030 400043 400045 400046 400049 400050 400065 400067 400068 400069 400070 400081 400082 400084 400085 400086 400087 400088 400089 400090 400091 400092 400102 400104 400105 400106 400107 400108 400109 400111 400112 400113 400114 400115 400116 400117 400118 400120 400121 400122 400124 400125 400126 400127 400128 400129 400130 400131 400135 400138 400139 400140 400141 400142 400144 400145 400146 400147 400148 400149 400150 400152 400153 400154 400155 400156 400157 400158 400159 400160 400161 400162 400163 400164 400165 400166 400167 400168 400170 400171 400172 400174 400175 400176 400177 400178 400179 400180 400181 400182 400183 400184 400185 400186 400187 400188 400189 400191 400192 400194 400195 400196 400197 400199 400200 400201 400202 400203 400204 400205 400206 400207 400208 400209 400211 400212 400213 400214 400215 400216 400217 400218 400219 400220 400221 400222 400223 400224 400225 400226 400227 400228 400229 400230 400231 400232 400233 400234 400235 400236 400237 400238 400239 400240 400241 400242 400243 400244 400245 400246 400247 400248 400249 400250 400251 400252 400253 400254 400255 400256 400257 400258 400259 400260 400262 400263 400264 400265 400266 400267 400268 400269 400270 400271 400272 400273 400274 400275 400276 400277 400278 400279 400280 400281 400282 400283 400284 400285 400286 400287 400288 400289 400290 400291 400292 400293 400294 400295 400296 400297 400298 400299 400300 400301 400302 400303 400304 400306 400308 400309 400313 400314 400315 400316 400317 400318 400319 400320 400321 400322 400323 400324 400325 400326 400327 400328 400329 400330 400332 400333 400334 400335 400336 400337 400338 400339 400341 400342 400343 400344 400345 400346 400347 400348 400349 400350 400351 400354 400355 400401 400402 400403 400404 400405 400406 400407 400412 400413 400414 400415 400416 400417 400418 400419 400420 400421 400422 400423 400424 400425 400426 400427 400428 400429 400430 400432 400434 400435 400436 400437 400438 400439 400440 400441 400442 400443 400446 400447 400448 400449 400450 400451 400452 400453 400454 400455 400456 400457 400458 400459 400460 400461 400462 400463 400464 400465 400466 400467 400468 400469 400470 400471 400472 400473 400474 400475 400476 400477 400478 400479 400480 400481 400482 400483 400484 400485 400486 400487 400488 400489 400490 400491 400492 400493 400494 400495 400496 400497 400498 400499 400500 400501 400510 400511 400512 400513 400514 400515 400516 400517 400518 400519 400520 400521 400522 400523 400524 400525 400526 400527 400528 400529 400531 400532 400535 400536 400537 400538 400539 400540 400541 400542 400543 400544 400545 400546 400547 400549 400550 400551 400552, and 400556.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
P.O. Box 7393
Mountain View, California 94043
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Sheila Pickering
650-694-5398
Manufacturer Reason
for Recall
When using the 8V3c transducer in color mode, the derated Ispta 3 (Spatial Peak-Temporal Average Intensity) may exceed the limit stated in the instructions for use.
FDA Determined
Cause 2
DESIGN: Software Design
Action A Customer Safety Advisory Notification was initiated on 2/4/2011 and sent via certified mail. The letter identified the affected product and described when the problem occurs along with the associated potential risk. The firm recommends that users not use the 8V3c until the software issue is fixed. The firm is working to release a software update and customers' local Customer Service Engineer will install new software on their system when it is available. Customers should direct their questions to their local service support person. The information in the letter should be shared with all personnel within the organization who need to be aware.
Quantity in Commerce 386 units
Distribution Worldwide Distribution.
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 = IYN and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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