FDAFDA · Food and drugs·Recall number Z-1962-2014
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
Published July 9, 2014 · Recall initiated: June 3, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on the ACUSON S Family ultrasound system.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Distributor
- Worldwide Distribution - USA including CA, MO, VA, PA, WV, and Internationally to Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, France, Germany, Greece, India, Iraq, Israel, Italy, Japan, Kazakhstan, Malaysia, Mexico, Morocco, Netherlands, Norway, P.R. China, Philippines, Poland, Portugal, Republic Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., Ukraine, United Kingdom.
- Lot
- 10041461, 10440017 - S2000 system 10441730 - S3000 system 10441701 -S1000 system US Serial numbers: 206555 208590 208609 210104 210121 210187 210103 201296 201355 202477 206011 208663 210186 210172 210173 210178 210188 210257 200379 201754 202985 206249 206592 206715 206746 207626 207735 207737 207755 207940 207944 208654 208668 208718 208772 208775 208790 208903 208912 208913 210112 210229 210260 201382 206829 208902 208908 202372 202373 210119 210677 202063 203127 206492 207586 207613 208637 208701 208867 210361 201186 208554 210018 210039 210058 210227 201216 201186 208142 208153 210128 210179 210181 210183 210185 210191 210258 210268 210334 210451 208606 210149 210212 210236 210357 200128 210536 210565 210189 210170 202133 210166 210171 210310 210352 210485 210552 210559 200620 203593 200360 203253 203552 207041 210159 208733 210235 210242 210124 210474 210299 210329 208029 208047 208082 208527 207324 210285 208610 208807 208843 210233 210234 210246 206629 210157 205322 206538 208052 208825 208834 208838 202862 208752 210010 210176 210264 210269 210277 210304 210312 210414 210479 210487 207616 207648 207649 208010 208159 210385 201141 201210 203247 208984 210337 210348 210355 210495 210539 203414 210062 201430 210035 200113 207270 207276 207279 210034 210118 210184 210205 210298 210301 210311 210319 201350 205489 206529 208919 208920 210096 210195 207522 207647 210371 210254 210263 207272 207280 207287 207294 210470 200327 210308 210531 201125 208941 200319 202832 207609 210665 210679 207258 207296 207435 207467 207749 207952 210163 210164 210321 210383 210392 210433 210439 210664 207348 208603 210036 210152 210270 210326 210347 210397 207600 207697 207699 210134 210135 210255 210402 207674 201433 205152 207658 208072 208905 210046 210053 210055 210061 210063 210143 210153 210199 210204 210209 210215 210240 210241 210265 210274 210295 210324 210343 210667 201351 201354 202978 210026 210248 210300 208330 208376 210032 210038 210042 210044 210162 210203 210207 210213 210214 210217 210223 210379 210388 208959 210244 210358 201070 210148 210197 207288 207917 208958 210287 210309 210366 201344 207002 207029 206299 206312 210180 207759 207771 207787 207788 207838 206024 210220 210238 210239 210245 207411 208779 210009 210276 210331 210369 207651 208747 208785 ROW Serial numbers: 208880 202873 207580 210074 210081 210168 210206 210363 210368 210415 210110 210253 210340 210456 208666 208692 201012 201947 202994 208758 210105 210360 210403 210408 210445 208622 210037 206678 208676 208837 208904 208942 208948 208949 208657 210320 207922 210095 210225 210380 208841 210218 210296 208826 210356 210364 210378 210106 210101 210282 200762 202106 202191 205228 205283 206355 210073 210146 210155 210252 210267 210280 210281 210286 210288 210290 210292 210297 210303 210306 210377 210384 210400 210401 210404 210405 210438 210447 210490 206859 207047 207160 207303 207670 207906 210316 210431 210668 208102 208552 210156 210167 210175 210177 210302 210375 200217 200688 200908 203107 206644 206739 206787 206908 207240 207624 208522 208536 208694 210001 210021 210023 210024 210028 210030 210041 210043 210052 210065 210066 210067 210069 210070 210080 210086 210087 210089 210094 210098 210114 210122 210141 210142 210145 210151 210192 210193 210210 210243 210250 210272 210284 210419 201275 207292 207556 207634 208755 208842 210050 210059 210068 210071 210078 210092 210093 210097 210100 210102 210115 210129 210132 210150 210219 210222 210273 210353 210372 210386 210413 210
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.