Syngo — Class II medical device recall Z-2853-2016
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2016-09-28, distributed nationwide. Software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volum
| Recall number | Z-2853-2016 |
|---|---|
| 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 | 2016-08-05 |
| Classified | 2016-09-21 |
| Reported by FDA | 2016-09-28 |
| Terminated | 2017-08-22 |
| Distributed | Nationwide (US) |
| Quantity | 338 systems |
| Reason classes | software |
| Serial numbers | 100008, 100012, 100039, 100411, 100417, 100418, 100419, 100420, 100421, 100484, 100485, 100518, 100583, 100590, 100598, 100620, 100633, 100641, 100642, 100643, 100644, 100645, 100646, 100662, 100669 and 313 more |
Product
Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
Reason for recall
Software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver were too high.
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-2853-2016. 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.