Siemens SOMATOM CT Scanner Software Recall for System Crashes
Siemens Medical Solutions is recalling syngo CT VB20 software for SOMATOM CT scanners due to scan aborts and system crashes.
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 does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling software versions syngo CT VB20 running on specific Siemens SOMATOM CT Scanners. The affected models include the SOMATOM Force, SOMATOM Definition As, SOMATOM Definition Edge, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Confidence, and SOMATOM Edge Plus.
The recall is being conducted because the software has an issue that causes scan aborts and system crashes. A total of 305 units were distributed nationwide.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the software issue.
The recalled product
- Product
- Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027), SOMATOM Definition Edge (Model #10590000), SOMATOM Definition Flash (Model #10430603), SOMATOM Drive (Model…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 305
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)
- Software versions syngo CT VB20
Distribution
Distributed nationwide across the United States.
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