Siemens SOMATOM Confidence CT Scanners Recalled for Software-Related Workflow Interruptions
Siemens SOMATOM Confidence CT scanners may experience software-related workflow interruptions that could delay patient diagnosis. The recall affects 104 units nationwide; affected facilities should contact the manufacturer for remediation instructions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves medical imaging equipment without reported illnesses or injuries. The software defect poses a risk of delayed patient diagnosis through workflow interruptions, meeting the rubric criterion for High-severity risk-of-harm products where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration has issued a Class II recall of Siemens SOMATOM Confidence CT scanners (Model #10590100) with syngo.CT VB20 software. The recall affects 104 units distributed nationwide.
The software syngo.CT VB20, including versions SP1 through SP4, may cause workflow interruptions during the CT scanning process. These interruptions can result in delays in diagnosis, may require patients to undergo additional rescans, and may necessitate additional contrast media administration.
Facilities with affected devices should verify their unit serial numbers against the recall list. Contact Siemens Medical Solutions USA, Inc. for remediation instructions.
The recalled product
- Product
- SOMATOM Confidence with software syngo.CT VB20 Model #10590100
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- workflow-interruption
- delayed-diagnosis
- software-malfunction
Distribution
Distributed nationwide across the United States.
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