Siemens ACUSON SC2000 Ultrasound System Recalled for Trackball Control Failure
Siemens is recalling 87 ACUSON SC2000 ultrasound systems because the trackball may fail to control specific imaging parameters during transesophageal 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, but the source text describes a functional software defect without reporting any injuries, illnesses, or hospitalizations. This aligns with the 'Moderate' criteria for voluntary precautionary recalls or minor functional issues where harm has not been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 87 units of the ACUSON SC2000 Ultrasound imaging system. The affected units are equipped with software version VB10C and use transesophageal (TEE) transducers Z6Ms, V5Ms, or V7M. The specific model number is 10433816.
The recall is due to a software defect where the user may lose the ability to control the color region of interest, the pulsed wave or continuous wave Doppler gate or cursor, the M-mode cursor, the 2D field of view, or the RES region of interest with the trackball. This issue occurs specifically while imaging with the affected TEE transducers.
The affected units were distributed worldwide, including in the United States, Austria, Canada, China, Germany, India, Italy, Spain, Sweden, and Switzerland. Users should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the issue.
The recalled product
- Product
- ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model number: 10433816.
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 87
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)
- Model number 10433816
Distribution
Distributed nationwide across the United States.
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