ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number:… — Class II medical device recall Z-1340-2020
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2020-02-26, distributed nationwide. Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the ev
| Recall number | Z-1340-2020 |
|---|---|
| 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 | 2020-01-24 |
| Classified | 2020-02-20 |
| Reported by FDA | 2020-02-26 |
| Terminated | 2020-07-10 |
| Distributed | Nationwide (US) |
| Quantity | 96 us |
| Model numbers | 10849000 |
Product
ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM 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. Procedures that can be performed with the AXIOM Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Axiom Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
Reason for recall
Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the robotic stand can no longer perform the intended movements
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-1340-2020. 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.