Software versions syngo CT VB20 running on the following Siemens… — Class II medical device recall Z-0406-2020
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2019-11-20, distributed nationwide. Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanner: scan abort
| Recall number | Z-0406-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2019-10-07 |
| Classified | 2019-11-14 |
| Reported by FDA | 2019-11-20 |
| Terminated | 2022-11-14 |
| Distributed | Nationwide (US) |
| Quantity | 305 units |
| Reason classes | software |
| Model numbers | 10267000, 10430603, 10431700, 10590000, 10590100, 10742326, 8098027 |
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 #10431700), SOMATOM Confidence (Model #10590100), and SOMATOM Edge Plus (Model # 10267000) with software syngo CT VB20
Reason for recall
Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanner: scan aborts and system crashes
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.