Reported Jul 9, 2014 · Terminated

ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems)…

Siemens Medical Solutions USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Medical Solutions USA, Inc. · 685 E Middlefield Rd · Mountain View, CA · 94043-4045

Is this the product you have?

  • 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.
Lot codes and dates
  • 10041461, 10440017 - S2000 system 10441730 - S3000 system 10441701 -S1000
  • system US Serial numbers

    314 of 314 codes

    • 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
  • ROW Serial numbers

    476 of 476 codes

    • 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
Amount recalled
790 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 25, 2016 · Data as of Sep 19, 5:30 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.