Artis zee — Class II medical device recall Z-2686-2017
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2017-07-26, distributed in AR, IA, IL, KS, MI, MN, NY, OH…. Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain de
| Recall number | Z-2686-2017 |
|---|---|
| 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 | 2017-02-03 |
| Classified | 2017-07-14 |
| Reported by FDA | 2017-07-26 |
| Terminated | 2017-10-24 |
| Distributed | AR, IA, IL, KS, MI, MN, NY, OH, WI, WV |
| Serial numbers | 124061, 124081, 131101, 137391, 137662, 137668, 147871, 148001, 153197, 154035, 154827, 154847 |
Product
Artis zee,x-ray system, angiographic Artis zee 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 Artis zee include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee systems can also support the acquisition of position triggered imaging for spatial data synthesis
Reason for recall
Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain delivery lot and 2-focus Megalix Cat Plus tube unit.
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-2686-2017. 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.