Syngo Imaging version V31 — Class II medical device recall Z-0405-2018
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2018-01-31, distributed nationwide. Siemens is releasing a letter to inform about potential data loss relevant to diagnosis.
| Recall number | Z-0405-2018 |
|---|---|
| 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 | 2017-07-25 |
| Classified | 2018-01-23 |
| Reported by FDA | 2018-01-31 |
| Terminated | 2018-07-23 |
| Distributed | Nationwide (US) |
| Quantity | 36 units |
| Serial numbers | 1005, 1043, 1049, 1053, 1055, 1058, 1064, 1065, 1074, 1079, 1081, 1082, 1083, 1090, 1107, 1116, 1198, 1218, 1226, 1279, 1310, 1316, 1322, 1329, 1334 and 11 more |
| Model numbers | 10014063 |
Product
Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. It supports the physician in diagnosis and treatment planning.
Reason for recall
Siemens is releasing a letter to inform about potential data loss relevant to diagnosis.
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-0405-2018. 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.