Artis icono biplane -angiography systems developed for single and… — Class II medical device recall Z-1245-2022
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-1245-2022 |
|---|---|
| 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 | 51 units |
| UPC / GTIN / UDI-DI | 04056869063317 |
| Serial numbers | 180014, 180015, 180018, 180019, 180021, 180029, 180034, 180035, 180037, 180040, 180041, 180043, 180046, 180047, 180048, 180049, 180053, 180054, 180055, 180056, 180057, 180060, 180062, 180065, 180066 and 26 more |
Product
Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
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-1245-2022. 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.