CT Scanner Software Issue Causes Workflow Interruptions and Diagnostic Delays
Siemens SOMATOM Definition Flash CT scanners with syngo.CT VB20 software may experience workflow interruptions that delay diagnoses and require additional rescans and contrast media. This recall affects 121 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 3/5 (High).
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 medical device presents a risk-of-harm situation involving a diagnostic imaging system with potential for delayed diagnoses where no injuries or illnesses have been reported. The software defect may cause workflow disruptions and operational impacts.
Plain-English summary
The Siemens SOMATOM Definition Flash CT scanner (Model #10430603) running syngo.CT VB20 software is being recalled due to a software defect. The affected software may cause workflow interruptions that result in delayed diagnosis, the need for patient rescans, and additional contrast media administration.
The recall affects 121 units that have been distributed nationwide in the United States. Affected units are identified by specific serial numbers. Healthcare facilities should check whether their equipment is included in this recall by comparing their device serial number to the provided list and contact Siemens Medical Solutions USA, Inc. for software updates or corrective instructions.
The recalled product
- Product
- SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — CT Scanner
- Affected units
- 121
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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