Siemens ACUSON S Family Ultrasound Systems Recalled for Measurement Error
Siemens is recalling ACUSON S 1000, S 2000, and S 3000 ultrasound systems due to a potential measurement error in the Doppler manual trace tool that could lead to misdiagnosis.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury or misdiagnosis has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling ACUSON S 1000, ACUSON S 2000, and ACUSON S 3000 ultrasound systems. The recall involves 1,789 units distributed worldwide, including the United States, Puerto Rico, and numerous international countries.
The recall is due to a potential measurement error that occurs when using the Doppler manual trace measurement tool in full-screen format. This error has a low probability of causing a misdiagnosis. The affected systems are intended for various radiology applications, including fetal, abdominal, cardiac, and vascular imaging.
Healthcare facilities and users should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the issue. The source text does not specify a particular corrective action such as a software update or replacement, but the manufacturer is responsible for managing the recall.
The recalled product
- Product
- ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 1,789
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 (6)
- Model numbers: 10041461
- 10440017 S2000 system 10441730 S3000 system 10441701 S1000 system
- software version VC30A
- VC30B
- VC30C
- or VC31A
Distribution
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