ARTIS Pheno — Class II medical device recall Z-2108-2020
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2020-06-03, distributed nationwide. If the C-arm leaves its intended travel path due to a fault within the drivetrain, movements may be impacted o
| Recall number | Z-2108-2020 |
|---|---|
| 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 | 2020-04-22 |
| Classified | 2020-05-22 |
| Reported by FDA | 2020-06-03 |
| Terminated | 2020-10-09 |
| Distributed | Nationwide (US) |
| Quantity | 105 systems |
| Serial numbers | 164011, 164013, 164018, 164019, 164021, 164022, 164024, 164025, 164026, 164027, 164028, 164033, 164034, 164048, 164049, 164053, 164054, 164055, 164057, 164060, 164061, 164063, 164064, 164066, 164068 and 80 more |
| Model numbers | 10849000 |
Product
ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 - Product Usage: 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
If the C-arm leaves its intended travel path due to a fault within the drivetrain, movements may be impacted or impossible and the area of interest cannot be reached. In the event the C-arms movements are not possible, the system can only be returned to normal operation with the support of a field service engineer
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-2108-2020. 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.