AXIOM Artis zee/zeego — Class II medical device recall Z-1283-2016
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2016-04-06, distributed nationwide. Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant
| Recall number | Z-1283-2016 |
|---|---|
| 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 | 2016-02-18 |
| Classified | 2016-03-31 |
| Reported by FDA | 2016-04-06 |
| Terminated | 2017-08-08 |
| Distributed | Nationwide (US) |
| Quantity | 986 systems |
| Reason classes | packaging |
| Serial numbers | 121004, 121006, 121008, 121009, 121010, 121011, 121012, 121013, 121014, 121015, 121016, 121018, 121019, 121020, 121023, 121027, 121034, 121036, 121037, 121039, 121040, 121041, 121046, 121047, 121049 and 36 more |
Product
AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q.zen 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 zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
Reason for recall
Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can result in a cooling system failure and subsequent system failure. 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-1283-2016. 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.