Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1959-2015·Announced 2015-07-08

Siemens ACUSON SC2000 Ultrasound Systems Recalled for Data Loss

Siemens Medical Solutions USA is recalling 573 ACUSON SC2000 ultrasound systems because specific keystrokes during 2D Stress Echo studies may cause selected clips to not be saved.

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, but the hazard is a software data integrity issue (loss of clips) rather than a direct physical injury or death risk, fitting the 'Moderate' criteria for non-physical defects or low-risk issues.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 573 ACUSON SC2000 Ultrasound Systems. The affected devices are identified by model number 10433816 and are equipped with software versions between VA16A and VA30A, specifically those with the Stress Echo Option. These systems are intended for various applications including cardiac, neonatal and fetal cardiac, pediatric, and transesophageal imaging.

The recall is due to a software issue where performing specific keystrokes during a 2D Stress Echo study may result in a potential loss of data. Specifically, some selected clips may not be saved as part of the study. This issue affects the integrity of the recorded data rather than posing a direct physical safety hazard to the patient or operator.

The affected devices were distributed worldwide, including in the United States and numerous other countries such as Australia, Canada, Germany, Japan, and the United Kingdom. Users of these systems should check their device model and software version against the recall notice to determine if they are affected. Siemens Medical Solutions USA, Inc. is the recalling firm responsible for addressing this issue.

The recalled product

Product: ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number 10433816: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric…
Manufacturer: Siemens Medical Solutions USA, Inc.
Category: Medical Device — Ultrasound Imaging
Hazard: data-loss
software-defect
Affected units: 573

Distribution

Distribution scope not specified by the agency.

Same manufacturer · Siemens Medical Solutions USA, Inc.

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