RecallRadar

FDA Device recall Z-1962-2014

ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B

On 2014-07-09 the FDA classified a Class II recall of ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B by Siemens Medical Solutions Usa, citing there is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on the ACUSON S Family ultrasound system.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1962-2014
ClassificationClass II
Statusterminated
Initiated2014-06-03
Published2014-07-09
Last updated2026-09-13 11:53 UTC
CompanySiemens Medical Solutions Usa
DistributionCA, MO, PA, VA, WV

Product

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.

Reason

There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on the ACUSON S Family ultrasound system.

Identifiers

code_info
10041461, 10440017 - S2000 system 10441730 - S3000 system 10441701 -S1000 system US Serial numbers: 206555 208590…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1962-2014%22

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