Siemens ACUSON SC2000 Ultrasound Systems Recalled for Software Malfunction
Siemens is recalling 177 ACUSON SC2000 ultrasound systems due to a software issue in the Stress Echo feature that may require studies to be repeated.
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 hazard is a software malfunction that may require studies to be repeated, which aligns with the rubric for moderate severity issues involving potential operational disruption without reported physical injury.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 177 ACUSON SC2000 Ultrasound Systems equipped with software version 3.5 (VA35) and using the Stress Echo Feature. The recall is due to a potential software malfunction that could cause the need for the study to be repeated.
The affected units were distributed nationwide in the United States and internationally to Australia, Belarus, the Dominican Republic, France, Germany, India, Indonesia, Israel, Japan, Mexico, New Zealand, Norway, the Philippines, Poland, the Republic of Korea, Romania, the Russian Federation, Saudi Arabia, Singapore, Sweden, Switzerland, Turkey, the U.A.E., Ukraine, and the United Kingdom.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the software issue and manage affected studies.
The recalled product
- Product
- ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging system.
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Hazard
- Affected units
- 177
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)
- ACUSON SC2000 model number: 10433816
Distribution
Distributed nationwide across the United States.
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