Syngo — Class II medical device recall Z-0808-2018
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2018-03-07, distributed nationwide. A software update was released on August 22, 2017. Performing this software installation and upgrading syngo.v
| Recall number | Z-0808-2018 |
|---|---|
| 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 | 2017-08-31 |
| Classified | 2018-03-01 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2018-10-01 |
| Distributed | Nationwide (US) |
| Quantity | 30 |
| Reason classes | software |
Product
Syngo.via systems with SW VB20A
Reason for recall
A software update was released on August 22, 2017. Performing this software installation and upgrading syngo.via system to the software version VB20A_HF02 will resolve various bugs and inconsistent diagnosis with the old system.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0808-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.