Siemens ACUSON SC2000 Ultrasound Systems Recalled for Image Loss
Siemens Medical Solutions USA is recalling 476 ACUSON SC2000 ultrasound systems because post-exercise images may be lost during Stress Echo procedures.
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. The hazard involves the loss of diagnostic images, which is a functional defect without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 476 ACUSON SC2000 ultrasound systems (Model number 10433816) at software versions VA20A or VA20B. The recall is due to a defect where post-exercise images can be lost in Stress Echo applications.
The affected systems are intended for various medical imaging applications, including Cardiac, Neonatal and Fetal Cardiac, Pediatric, and Transesophageal imaging. The recall covers units distributed worldwide, including in the United States and numerous international locations such as Australia, Canada, Germany, and Japan.
Healthcare providers should contact Siemens Medical Solutions USA for instructions on how to address the issue. The specific serial numbers for the affected units are listed in the official recall documentation.
The recalled product
- Product
- ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel…
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 476
Distribution
Distribution scope not specified by the agency.
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