Siemens ACUSON S Family Ultrasound Systems Recalled for Measurement Error
Siemens Medical Solutions is recalling ACUSON S Family ultrasound systems due to a potential measurement error in the Auto-Stats tool.
What this means for you
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 situation where use of the product could cause temporary or medically reversible health consequences. The source text describes a potential measurement error without reporting specific injuries or hospitalizations, fitting the Moderate severity criteria for a device defect with theoretical risk.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling ACUSON S Family Ultrasound Systems, including S2000, S3000, and S1000 models, at software versions VC25D, VC30A, and VC30B. The recall involves 790 units distributed worldwide, including in the United States and numerous international locations.
The recall is issued because there is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on these systems. This defect may affect the accuracy of the automated statistical measurements provided by the device.
Healthcare facilities and users should check their equipment serial numbers against the list provided in the official recall notice to determine if their system is affected. Siemens Medical Solutions is the recalling firm responsible for addressing this issue.
The recalled product
- Product
- ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Hazard
- Affected units
- 790
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)
- 10041461
Distribution
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