Artis One — Class II medical device recall Z-1119-2015
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2015-02-25, distributed nationwide. The possibility exists that the monitor may fail and requires a power circle (shutdown and then power on) to r
| Recall number | Z-1119-2015 |
|---|---|
| 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 | 2015-01-16 |
| Classified | 2015-02-17 |
| Reported by FDA | 2015-02-25 |
| Terminated | 2015-04-21 |
| Distributed | Nationwide (US) |
| Quantity | 1 |
| Reason classes | device malfunction |
| Serial numbers | 82010 |
| Model numbers | 10848600 |
Product
Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities. Additionally, angiographic procedures can be performed in the operating room, image guided surgery by x-ray, by image fusion, and by navigation systems.
Reason for recall
The possibility exists that the monitor may fail and requires a power circle (shutdown and then power on) to resume operation. The problem is not systematic; but sporadic on single units.
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-1119-2015. 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.