Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2783-2015·Announced 2015-09-23

Siemens ACUSON SC2000 Ultrasound System Recalled for Data Capture Error

Siemens is recalling ACUSON SC2000 ultrasound systems because a software error prevents the capture of images or clips when patient names are registered with different capitalization.

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. The hazard is a software defect leading to data loss (failure to capture images), which is a significant functional issue but does not involve direct physical injury, death, or high-risk biological pathogens, fitting the Moderate category for non-injurious functional defects.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 2,039 ACUSON SC2000 ultrasound systems, Model 10433816, equipped with software versions VB10B and lower. The recall is due to a software defect where the system treats uppercase and lowercase differences in the same patient name as unique patient instances.

If these capitalization differences are not corrected at the time of registration, the system fails to capture images or clips. This issue affects the system's ability to store data for clinical diagnosis purposes.

The affected devices were distributed worldwide, including the United States and numerous international markets. Siemens is the recalling firm. No specific consumer action is detailed in the provided source text beyond the identification of the defect.

The recalled product

Product: ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic…
Manufacturer: Siemens Medical Solutions USA, Inc.
Category: Medical Device — Ultrasound System
Hazard: software-defect
data-loss
Affected units: 2,039

Distribution

Distributed nationwide across the United States.

Same manufacturer · Siemens Medical Solutions USA, Inc.

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