Siemens ACUSON SC2000 Ultrasound Systems Recalled for Software Display Errors
Siemens is recalling 257 ACUSON SC2000 ultrasound systems due to software issues that may cause incorrect color flow data display and Doppler waveform failures.
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 source text describes software display and functionality issues without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 257 units of ACUSON SC2000 Ultrasound Systems equipped with software version 3.5 (VA35). The recall is due to software issues that may cause the system to incorrectly display color flow data in the wrong position. Additionally, when the Doppler Frequency is adjusted, the system may fail to restart the pulsed wave Doppler or continuous wave Doppler waveform.
The affected units were distributed worldwide, including in the United States and various international markets. The specific serial numbers for the affected units are listed in the official recall documentation.
Healthcare providers should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the software issues. Consumers and patients should consult their healthcare providers regarding the use of these devices.
The recalled product
- Product
- ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system.
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 257
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)
- Model number 10433816
Distribution
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