CLASS II Device recall · Reported 18 Feb 2015 · FDA Enforcement Report

Acuson S2000 Automated Breast Volume Scanner (Abvs) recalled

Siemens Medical Solutions USA is recalling Acuson S2000 Automated Breast Volume Scanner (Abvs), distributed in Minnesota, Texas. The recall was initiated on 12 Jan 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial numbers 250157-250190.

Quantity recalled24 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-1063-2015
FDA event ID: 70361
Recalling firm: Siemens Medical Solutions USA, Mountain View, CA
Classification: Class II
Status: Terminated
Recall initiated: 12 Jan 2015
FDA classified: 7 Feb 2015
Reported: 18 Feb 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

12 Jan 2015	Recall initiated by company
7 Feb 2015	Classified by FDA	+26 days
18 Feb 2015	Published in enforcement report	+11 days

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

Reason for recall

There is a low probability the scanner arm will become completely detached from the scanner column.

Product as listed by the FDA

ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 - Boom Welding and 10434969 - Arm Welding. The S2000 ABVS ultrasound System for imaging the breast allows volumetric acquisition of the breast image.

Where it was distributed

Worldwide Distribution -- US, including the states of TX and MN, and the territory of P.R.; and, the countries of China, Germany, Russian Fed, Saudi Arabia, Taiwan, France, Thailand, and Italy.

Minnesota Texas

Questions about this recall

Is Acuson S2000 Automated Breast Volume Scanner (Abvs) recalled?

Yes. Siemens Medical Solutions USA recalled Acuson S2000 Automated Breast Volume Scanner (Abvs) on 12 Jan 2015. The recall is Class II and its status is Terminated. Recall number Z-1063-2015.

Why was it recalled?

There is a low probability the scanner arm will become completely detached from the scanner column.

Which lots are affected?

Serial numbers 250157-250190.

Where was it sold?

Worldwide Distribution -- US, including the states of TX and MN, and the territory of P.R.; and, the countries of China, Germany, Russian Fed, Saudi Arabia, Taiwan, France, Thailand, and Italy.

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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