Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ACUSON S2000 Automated Breast Volume Scanner (ABVS) Recalled by Siemens Medical Solutions USA, Inc. Due to On some ACUSON S2000 ABVS systems, the inside...

Date: January 18, 2013
Company: Siemens Medical Solutions USA, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Medical Solutions USA, Inc. directly.

Affected Products

ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business Unit: Ultrasound. The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging of the breast allows volumetric acquisition of the breast image.

Quantity: 214 affected devices

Why Was This Recalled?

On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges.

Where Was This Sold?

This product was distributed to 2 states: OH, WV

Affected (2 states)Not affected

About Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc. has 87 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report