Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1668-2014·Announced 2014-06-04

Siemens ACUSON SC2000 Ultrasound Systems Recalled for Software Malfunction

Siemens is recalling 177 ACUSON SC2000 ultrasound systems due to a software issue in the Stress Echo feature that may require studies to be repeated.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a software malfunction that may require studies to be repeated, which aligns with the rubric for moderate severity issues involving potential operational disruption without reported physical injury.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 177 ACUSON SC2000 Ultrasound Systems equipped with software version 3.5 (VA35) and using the Stress Echo Feature. The recall is due to a potential software malfunction that could cause the need for the study to be repeated.

The affected units were distributed nationwide in the United States and internationally to Australia, Belarus, the Dominican Republic, France, Germany, India, Indonesia, Israel, Japan, Mexico, New Zealand, Norway, the Philippines, Poland, the Republic of Korea, Romania, the Russian Federation, Saudi Arabia, Singapore, Sweden, Switzerland, Turkey, the U.A.E., Ukraine, and the United Kingdom.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the software issue and manage affected studies.

The recalled product

Product: ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging system.
Manufacturer: Siemens Medical Solutions USA, Inc.
Category: Medical Device — Ultrasound Imaging
Hazard: software-malfunction
Affected units: 177

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

ACUSON SC2000 model number: 10433816

Distribution

Distributed nationwide across the United States.

Same manufacturer · Siemens Medical Solutions USA, Inc.

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