Siemens CT Scanner Software May Cause Diagnostic Workflow Delays
Siemens SOMATOM Definition Edge CT scanners with syngo.CT VB20 software may experience workflow interruptions, causing diagnostic delays, need for repeat scans, and additional contrast media use. 298 units nationwide are affected.
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: Class II recall with software defect affecting diagnostic workflow and capability. No hospitalizations or injuries reported, but the defect poses a risk-of-harm through potential diagnostic delays. Meets criteria for High severity as a risk-of-harm product without reported injury.
Plain-English summary
Siemens Medical Solutions USA is recalling 298 SOMATOM Definition Edge CT scanners (Model #10590000) with syngo.CT VB20 software nationwide. The software may cause workflow interruptions during normal operation.
When interruptions occur, they can result in delays in patient diagnosis, the necessity for repeat patient scans, and the need for additional contrast media. These workflow issues impact diagnostic capability and patient care efficiency.
Healthcare facilities using affected units should contact Siemens Medical Solutions immediately regarding available software updates and remediation options. Affected serial numbers are provided by the FDA. Healthcare providers should assess their use of these systems and implement corrective measures to prevent diagnostic delays.
The recalled product
- Product
- SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 298
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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