Artis zee/ zeego systems — Class II medical device recall Z-0854-2015
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2015-01-21, distributed in CA, CO, CT, HI, IN, LA, MD, ME…. The Small Focus of a 3 focal spot x-ray tube may fail and further release of radiation will not be possible. T
| Recall number | Z-0854-2015 |
|---|---|
| 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 | 2014-09-17 |
| Classified | 2015-01-14 |
| Reported by FDA | 2015-01-21 |
| Terminated | 2015-08-06 |
| Distributed | CA, CO, CT, HI, IN, LA, MD, ME, MI, MO, NY, OH, OK, PA, TX, VA, WA |
| Quantity | 44 |
| Reason classes | device malfunction |
| Serial numbers | 135862, 135927, 136345, 136503, 146427, 146630, 146643, 146729, 146742, 146883, 146896, 146940, 146972, 146986, 147009, 147029, 147098, 147129, 147144, 147155, 147208, 147372, 147378, 153195, 153220 and 19 more |
| Model numbers | 10094135, 10094137, 10094139, 10094141, 10280959 |
Product
Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
Reason for recall
The Small Focus of a 3 focal spot x-ray tube may fail and further release of radiation will not be possible. The Large Focus and Micro Focus focal spots will still be operational without any restriction. Manual switchover is needed, resulting in a short interruption of the procedure.
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-0854-2015. 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.