CLASS II Device recall · Reported 30 Oct 2013 · FDA Enforcement Report

Acuson SC2000 volume imaging ultrasound systems at recalled

Siemens Medical Solutions USA is recalling Acuson SC2000 volume imaging ultrasound systems at, distributed nationwide in the US. The recall was initiated on 10 Jul 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel# 10433816 Software Version 3.0 Serial#'s: 401239 401189 401214 400416 400599 400600 401254 401260 401259 401161 400836 401111 401290 400641 401116 401236 401245 401241 401255 401361 400141 401108 401109 401213 400675 400882

Quantity recalled26 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0052-2014
FDA event ID: 65812
Recalling firm: Siemens Medical Solutions USA, Mountain View, CA
Classification: Class II
Status: Terminated
Recall initiated: 10 Jul 2013
FDA classified: 23 Oct 2013
Reported: 30 Oct 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Imaging Equipment

Timeline

10 Jul 2013	Recall initiated by company
23 Oct 2013	Classified by FDA	+105 days
30 Oct 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Software issue results in inaccurate 3D image may result in ablation in wrong location.

Product as listed by the FDA

Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that provide information to the clinician for clinical diagnosis purposes.

Where it was distributed

Worldwide Distribution - US (nationwide) including the states of IL, PA, AZ, OR, OH, NY, CO, TX and CA., and the countries of France, Germany, Japan, Portugal, Saudi Arabia, Taiwan and Turkey.

Nationwide Arizona California Colorado Illinois New York Ohio Oregon Pennsylvania Texas

Questions about this recall

Is Acuson SC2000 volume imaging ultrasound systems at recalled?

Yes. Siemens Medical Solutions USA recalled Acuson SC2000 volume imaging ultrasound systems at on 10 Jul 2013. The recall is Class II and its status is Terminated. Recall number Z-0052-2014.

Why was it recalled?

Software issue results in inaccurate 3D image may result in ablation in wrong location.

Which lots are affected?

Model# 10433816 Software Version 3.0 Serial#'s: 401239 401189 401214 400416 400599 400600 401254 401260 401259 401161 400836 401111 401290 400641 401116 401236 401245 401241 401255 401361 400141 401108 401109 401213 400675 400882

Where was it sold?

Worldwide Distribution - US (nationwide) including the states of IL, PA, AZ, OR, OH, NY, CO, TX and CA., and the countries of France, Germany, Japan, Portugal, Saudi Arabia, Taiwan and Turkey.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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