Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1581-2015·Announced 2015-05-13

Siemens ACUSON SC2000 Ultrasound Systems Recalled for Image Capture Failures

Siemens is recalling 186 ACUSON SC2000 ultrasound systems because they may fail to capture images or clips during routine scans.

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, which typically indicates a temporary or medically reversible adverse health consequence. The specific defect is a software failure to capture images, which is a functional issue rather than a direct physical hazard like a shock or fire, fitting the Moderate category for a precautionary recall of a medical device.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 186 ACUSON SC2000 volume imaging ultrasound systems. The affected devices are Model 10433816 and operate on software versions VA16C, VA16D, and VA16E. These systems are used for various medical applications, including cardiac, pediatric, and abdominal imaging.

The recall was initiated because, in some cases, the systems are unable to capture a clip or image during a routine scan. This defect may prevent clinicians from obtaining necessary diagnostic data. The devices were distributed worldwide, including in the United States and numerous international locations.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the issue. The source text does not specify a specific action for end-users, as these are professional medical devices.

The recalled product

Product: ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal…
Manufacturer: Siemens Medical Solutions USA, Inc.
Category: Medical Device — Ultrasound Imaging
Hazard: software-defect
image-capture-failure
Affected units: 186

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 (2)

Model 10433816
software versions VA16C

Distribution

Distributed nationwide across the United States.

Same manufacturer · Siemens Medical Solutions USA, Inc.

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