ARTIS is a family of dedicated angiography systems developed for… — Class II medical device recall Z-2241-2024
Ongoing recall by Siemens AG/Siemens Healthcare GmbH, reported 2024-07-10, distributed nationwide. A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (mode
| Recall number | Z-2241-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Siemens AG/Siemens Healthcare GmbH, Forchheim, N/A, Germany |
| Recall initiated | 2024-06-26 |
| Classified | 2024-07-02 |
| Reported by FDA | 2024-07-10 |
| Distributed | Nationwide (US) |
| Quantity | 201 units |
| UPC / GTIN / UDI-DI | 04056869063317, 04056869149325, 04056869295923 |
Product
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Reason for recall
A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.
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-2241-2024. 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.