Syngo — Class II medical device recall Z-2245-2016
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2016-07-27, distributed nationwide. Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018/16/P to resol
| Recall number | Z-2245-2016 |
|---|---|
| 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 | 2016-06-23 |
| Classified | 2016-07-19 |
| Reported by FDA | 2016-07-27 |
| Terminated | 2020-02-20 |
| Distributed | Nationwide (US) |
| Quantity | 50 units |
| Reason classes | software |
Product
Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing, manipulation, communication, and storage of medical images.
Reason for recall
Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018/16/P to resolve software errors.
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-2245-2016. 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.