| Class 2 Device Recall ACUSON S2000 and ACUSON S3000 ultrasound systems | |
Date Initiated by Firm | June 25, 2015 |
Date Posted | July 30, 2015 |
Recall Status1 |
Terminated 3 on October 19, 2017 |
Recall Number | Z-2321-2015 |
Recall Event ID |
71688 |
510(K)Number | K132804 |
Product Classification |
System, imaging, pulsed doppler, ultrasonic - Product Code IYN
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Product | ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option;
Model numbers:
10041461, 10440017 -S2000 system
10441730 -S3000 system
VTIQ Option- 10439521 and 10439522
Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. |
Code Information |
Model numbers: 10041461, 10440017 - S2000 system; 10441730 - S3000 system; VTIQ Option - 10439521 and 10439522. Serial numbers for US: 210104 211147 211148 210257 211071 201387 201389 206511 206574 206592 206619 206732 206832 208718 208772 210931 211483 212156 212157 202555 210055 210061 210423 210426 210427 210629 206049 210032 210128 210334 210361 211742 211334 211156 211165 211215 211180 211183 208220 210666 211158 211338 211425 211611 212064 211091 210343 203158 211278 210692 210748 210777 210010 210479 211550 211551 205213 211123 211448 211709 210993 210164 210839 210954 210961 210672 200113 200140 202137 210034 210215 211777 207390 210505 210521 210861 200695 210759 210761 210764 210768 210769 201673 201979 206346 210265 210488 210573 210631 210667 210783 210825 210843 211124 211167 211174 211260 211316 211319 211320 211499 211513 211627 211635 211636 211637 211639 211643 211647 211649 212070 212133 212135 206901 210044 210169 210203 210213 210217 210506 210517 210708 210853 211168 211221 211273 211291 211295 211322 211401 211405 211467 211538 211558 211653 210278 207050 210844 211151 211092 211648 210035 212235 206969 202197 211217 207411 207438 207715 208219 208482 208645 210276 210674 211218 211267 211305 211321 211449 211620 211654 212131 201279 201281 210842 210855 210992 211066 211088. Serial numbers for ROW: 211768 210671 211803 212186 206153 206181 210340 210752 210763 211060 211182 211351 211705 210494 210935 207083 207298 207553 208176 203090 203106 206480 210105 210725 210799 211059 211262 210064 202134 203148 203282 203549 205242 205260 205381 206678 206756 206819 206857 207988 209048 209088 209120 211085 211397 206341 210085 211432 211445 210144 210225 210620 210793 211178 207878 210218 210707 210718 211041 208127 200974 202859 206917 210475 210691 210106 210073 210267 210280 210281 210288 210303 210306 210377 210400 210438 210490 210514 210749 210851 210860 210901 211095 211117 211624 211662 211775 212065 212162 212239 212287 200323 200734 206304 206369 207458 207855 207999 208046 208539 208578 210375 210583 211793 203107 206451 210021 210065 210066 210069 210094 210114 210141 210142 210145 210160 210161 210210 210243 210284 210338 210499 210523 210624 210625 210626 210627 210628 210632 210634 210758 210854 210874 211046 211072 211074 211122 211143 211146 211150 211152 211224 211225 211227 211264 211276 211457 211486 211490 211498 211544 211545 211548 211593 211598 212359 202330 206161 206537 207222 207226 208016 208249 208255 208264 210075 210076 210077 210083 210084 210088 210108 210109 210113 210123 210125 210126 210127 210198 210201 210211 210251 210927 211211 211619 210060 210151 210272 210574 211226 210880 210907 210948 210951 210966 211065 211087 211105 210049 210526 210538 210784 211083 211198 211560 208316 210387 211019 200291 200819 210881 207060 210279 210819 211726 207383 210831 211170 211186 200365 206042 206403 210117 210436 210437 210751 210922 210940 210963 210990 211129 211220 211281 211301 211324 211326 211346 211424 211464 211580 211697 211698 211701 211806 212149 212233 206044 206345 206388 206415 206481 206925 207267 207353 207563 207746 207943 208068 208070 208152 208193 208563 208576 208698 208878 210293 210315 210341 210374 210434 210457 210676 210845 210847 210915 211009 211063 211290 211345 210031 210608 205238 210442 211005 211011 211118 211258 211369 211729 212173 210914 211112 211125 210780 206761 206812 211272 200641 206450 211529 211530 211531 211532 211534 208557 208881 208945 208993 209065 209172 209213 209219 209221 209276 209315 209322 209340 209370 209535 209537 209597 209612 209614 209615 209625 209640 209648 209654 209702 209705 211242 200225 211623 210045 210342 211349 211712 207245 200853 203197 205424 207078 208682 210464 211187 206405 206679 207104 207800 208103 210165 210516 210773 202847 210190 210939 209627 211149 211048 210406 201937 202992 210942 211234 212139 207218 210047 210216 210294 210307 210395 210322 211808 205602 212158 206784 210871 210917 210919 210997 211153 211163 206666 206733 206734 208001 208056 208155 211420 200259 200708 202568 206406 207919 210090 211664 211764 210685 207589 208932 210082 210801 210955 211663 207621 210091 210586 210850 210989 211025 211068 211089 211127 211229 211494 208553 210452 210471 210736 211484 207023 210591 210594 210596 210599 210877 211220 211314 210333 210394 210417 210446 210450 210493 210512 210551 210598 210661 210929 211002 211012 211128 211130 211131 211135 211268 211365 211437 212165 212221 206740 207196 208146 208311 208628 208656 208787 208879 210766 211656. |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc. 685 E Middlefield Rd Mountain View CA 94043-4045
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For Additional Information Contact | Sheila Pickering, Ph.D. 650-694-9398 |
Manufacturer Reason for Recall | Potential measurement error on ACUSON S Family ultrasound system. When repositioning the Virtual Touch IQ region of interest from the original (default) location, the lateral position of the measurement tool may not align with the lateral position of the shear velocity data. |
FDA Determined Cause 2 | Software Design Change |
Action | On June 25, 2015 Customer Safety Advisory Notification letters were sent to all affected customers by Certified mail. The letter identified the affected product, problem and actions to be taken. The Siemens Service organization coordinates the implementation of the field correction with the distributors for all countries. For questions contact your Siemens Service for information. |
Quantity in Commerce | 629 units |
Distribution | Worldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Dominican Rep., France, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kenya, Malaysia, Mexico, Nepal, Netherlands, New Zealand, 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. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = IYN
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