Artis icono floor in combination with a Siemens Healthineers table or… — Class II medical device recall Z-0986-2022
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2022-04-27, distributed nationwide. Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Hea
| Recall number | Z-0986-2022 |
|---|---|
| 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 | 2022-02-25 |
| Classified | 2022-04-21 |
| Reported by FDA | 2022-04-27 |
| Distributed | Nationwide (US) |
| Quantity | 35 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04056869149325 |
| Serial numbers | 170023, 170025, 170026, 170027, 170051, 170053, 170303, 170304, 170305, 170307, 170309, 170310, 170312, 170319, 170322, 170328, 170331, 170332, 170333, 170334, 170336, 170343, 170346, 170349, 170351 and 10 more |
| Model numbers | 11327700 |
Product
Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327700
Reason for recall
Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are related to the block movements function and manual rotation of the flat detector. Depending on the status of the intervention, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where clinical treatment may be delayed until an additional restart is performed
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-0986-2022. 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.