Siemens ACUSON Ultrasound Systems Recalled for Measurement Alignment Error
Siemens is recalling ACUSON S2000 and S3000 ultrasound systems with Virtual Touch IQ due to a potential measurement alignment error.
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, and the source text describes a potential measurement error without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 629 units of ACUSON S2000 and ACUSON S3000 ultrasound systems equipped with the Virtual Touch IQ option. The affected model numbers are 10041461 and 10440017 for the S2000 system, 10441730 for the S3000 system, and 10439521 and 10439522 for the VTIQ option. These systems are intended for various radiology applications, including fetal, abdominal, cardiac, and vascular imaging.
The recall is issued because of a potential measurement error. When repositioning the Virtual Touch IQ region of interest from its original default location, the lateral position of the measurement tool may not align with the lateral position of the shear velocity data. This misalignment could affect the accuracy of the measurements taken during the procedure.
The affected units were distributed worldwide, including in the United States and numerous international locations. Healthcare providers and facilities using these specific ultrasound systems should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the issue.
The recalled product
- Product
- ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following application
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Hazard
- Affected units
- 629
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 (3)
- Model numbers: 10041461
- 10440017 - S2000 system
- 10441730 - S3000 system
Distribution
Distributed nationwide across the United States.
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