ARTIS icono systems with Quantification Application SW — Class II medical device recall Z-2257-2020
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2020-06-10, distributed in AZ, IL, UT, WI. Using Quantification Application (QVA/QCA) on DSA images may lead to a failure in vessel detection or incorrec
| Recall number | Z-2257-2020 |
|---|---|
| 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 | 2020-04-23 |
| Classified | 2020-06-03 |
| Reported by FDA | 2020-06-10 |
| Terminated | 2020-10-26 |
| Distributed | AZ, IL, UT, WI |
| Quantity | 5 us |
| Serial numbers | 180014, 180015, 180018, 180019, 180029 |
| Model numbers | 11327600 |
Product
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
Reason for recall
Using Quantification Application (QVA/QCA) on DSA images may lead to a failure in vessel detection or incorrect quantification of vessel detection and result in an incorrect diagnosis and inappropriate treatment of the patient
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-2257-2020. 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.