CT Scanner Software Issue Causes Workflow Interruptions and Diagnostic Delays
A software issue in SOMATOM Definition AS CT scanners may cause workflow interruptions, leading to diagnostic delays and the need for patient rescans. The recall affects approximately 665 units distributed nationwide.
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: FDA Class II recall without reported illnesses, injuries, or hospitalizations. The software issue causes workflow interruptions and diagnostic delays but no patient harm has been documented. This is a precautionary recall addressing an operational issue.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling SOMATOM Definition AS CT scanners (Model #8098027) equipped with syngo.CT VB20 software. The recall includes units running the base VB20 software as well as those with versions VB20_SP1, SP2, SP3, or SP4. A total of 665 units have been identified with nationwide distribution.
The software may result in workflow interruptions during diagnostic imaging procedures. These interruptions can lead to delays in patient diagnosis, necessitate patient rescans, and may require the administration of additional contrast media.
The affected units have been identified by specific serial numbers that are available in the official FDA recall documentation.
The recalled product
- Product
- SOMATOM Definition AS with software syngo.CT VB20 Model #8098027
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 665
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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