syngo — Class II medical device recall Z-1113-2019
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2019-04-17, distributed nationwide. There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning procedure. This r
| Recall number | Z-1113-2019 |
|---|---|
| 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 | 2019-03-21 |
| Classified | 2019-04-09 |
| Reported by FDA | 2019-04-17 |
| Terminated | 2022-01-11 |
| Distributed | Nationwide (US) |
| Quantity | 112 total |
| Reason classes | software |
| Model numbers | 10496180 |
Product
syngo.via syngo.CT Cardiac Planning, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis software packages for evaluating cardiac CT angiography (CTA) volume sets. The software packages are designed to support the physician in determining the functional parameters of the left and right ventricles, confirming the presence or absence of physicianidentified myocardial enhancement defects and evaluation documentation and follow-up of any such finding.
Reason for recall
There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning procedure. This risk is due to a software issue found in the TAVI algorithm.
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-1113-2019. 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.