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 SC2000 Ultrasound Systems with software version 3.5 (VA35) and Recalled by Siemens Medical Solutions USA, Inc. Due to Potential malfunction due to a software issue for...

Date: April 23, 2014
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 SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging system.

Quantity: 177 units

Why Was This Recalled?

Potential malfunction due to a software issue for ACUSON SC2000 ultrasound systems using software version 3.5 (VA35) when using the stress echo feature which could cause the need for the study to be repeated.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Siemens Medical Solutions USA, Inc.

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

Related Recalls

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