Artis icono floor-angiography systems developed for single and… — Class II medical device recall Z-1246-2022
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2022-06-15, distributed nationwide. if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the
| Recall number | Z-1246-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2022-04-11 |
| Classified | 2022-06-07 |
| Reported by FDA | 2022-06-15 |
| Distributed | Nationwide (US) |
| Quantity | 13 units |
| UPC / GTIN / UDI-DI | 04056869149325 |
| Serial numbers | 170023, 170025, 170026, 170027, 170051, 170053, 170303, 170304, 170305, 170307, 170309, 170310, 170312 |
Product
Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700
Reason for recall
if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm
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-1246-2022. 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.