Siemens CT Software Recall for Workflow Interruptions and Diagnostic Delays
Siemens Medical Solutions is recalling syngo.CT software versions VB20 and VB20_SP1 for 767 CT systems due to sporadic workflow interruptions that may delay diagnosis or require patient rescans.
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, and the source text describes workflow interruptions and diagnostic delays without reporting any injuries, hospitalizations, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling software versions syngo.CT VB20 and VB20_SP1 installed in specific SOMATOM CT systems. The affected systems include the SOMATOM Force, Definition As, Definition Edge, Definition Flash, Drive, Confidence, and Edge Plus models. A total of 767 units were distributed nationwide in the United States.
The recall is due to sporadic problems with the current software that may result in scanning workflow interruptions and unexpected user notifications. These issues can cause delays in diagnosis or require patients to be rescanned.
Healthcare facilities with affected systems should contact Siemens Medical Solutions for instructions on how to resolve the software issues. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 767
Distribution
Distributed nationwide across the United States.
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