CT Scanner Software May Cause Workflow Interruptions and Diagnosis Delays
Siemens SOMATOM Drive CT scanners with syngo.CT VB20 software may experience workflow interruptions that delay diagnosis and require additional patient scans. Approximately 75 units are affected nationwide.
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 is an FDA Class II recall of medical imaging equipment where software malfunctions may delay patient diagnosis. Although no injuries or hospitalizations have been reported, the potential for workflow interruptions affecting patient care in a diagnostic imaging setting constitutes a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The Siemens SOMATOM Drive CT scanner with syngo.CT VB20 software has been recalled due to potential workflow interruptions in the diagnostic imaging process. The software issue affects 75 units distributed nationwide in the United States. Affected software versions include VB20 and patches VB20_SP1 through VB20_SP4.
The software malfunction may interrupt the scanner's workflow, resulting in delays to patient diagnosis. These interruptions may necessitate additional patient scans and increased use of contrast media. The FDA has classified this recall as a Class II issue.
Patients and healthcare providers using affected SOMATOM Drive scanners should contact Siemens Medical Solutions USA, Inc. for information regarding available software updates or other corrective measures.
The recalled product
- Product
- SOMATOM Drive with software syngo.CT VB20 Model #10431700
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- software-malfunction
- workflow-interruption
- diagnosis-delay
Distribution
Distributed nationwide across the United States.
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