Syngo Dynamics — Class II medical device recall Z-1601-2016
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2016-05-11, distributed nationwide. Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syngo Dynamics. I
| Recall number | Z-1601-2016 |
|---|---|
| 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 | 2016-04-14 |
| Classified | 2016-05-04 |
| Reported by FDA | 2016-05-11 |
| Terminated | 2017-03-20 |
| Distributed | Nationwide (US) |
| Quantity | 84 units |
| Serial numbers | 85021, 85040, 85042, 85045, 85047, 85057, 85079, 85080, 85081, 85086, 85090, 85115, 85143, 85145, 85146, 85147, 85149, 85157, 85167, 85168, 85170, 85172, 85177, 85178, 85185 and 59 more |
| Model numbers | 10091637, 10091673, 10091805, 10091807 |
Product
Syngo Dynamics; Kinetdx Picture Archiving and Communications System
Reason for recall
Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syngo Dynamics. If the template design has measurements inside a carry forward-configured report section, this will result in carrying forward the entire section of the report including data from previous studies. This may result in the physician making analysis based on the old measurements.
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-1601-2016. 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.