Artis zee/zeego — Class II medical device recall Z-1311-2016
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2016-04-06, distributed nationwide. Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet. This leak can o
| Recall number | Z-1311-2016 |
|---|---|
| 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 | 2016-02-19 |
| Classified | 2016-03-31 |
| Reported by FDA | 2016-04-06 |
| Terminated | 2018-05-10 |
| Distributed | Nationwide (US) |
| Quantity | 1,757 systems |
| Reason classes | packaging |
| Model numbers | 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959, 5917054, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728392 |
Product
Artis zee/zeego (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography, general and rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
Reason for recall
Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet. This leak can occur sporadically in affected systems.
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-1311-2016. 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.