Artis Zee and Zeego — Class II medical device recall Z-0558-2019
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2018-12-12, distributed in AR, CA, KS, KY, MD, MN, NM, OK…. This recall has been initiated due to a possible leakage of a hose in the cooling unit of the X-ray tube. The
| Recall number | Z-0558-2019 |
|---|---|
| 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 | 2018-10-26 |
| Classified | 2018-12-05 |
| Reported by FDA | 2018-12-12 |
| Terminated | 2020-05-12 |
| Distributed | AR, CA, KS, KY, MD, MN, NM, OK, PA, RI, TX, UT |
| Quantity | 64 |
| Reason classes | packaging, device malfunction |
| Serial numbers | 908883-02, 908883-04, 908883-06, 908883-11, 908883-18, 908883-23, 910045-09, 910045-14, 910045-15, 910045-19, 910045-21, 910045-25, 911354-02, 911354-25, 911354-26, 911354-27 |
| Model numbers | 10272462 |
Product
Artis Zee and Zeego, model no. 10272462 AXIOM Artis zee/Zeego 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.
Reason for recall
This recall has been initiated due to a possible leakage of a hose in the cooling unit of the X-ray tube. The Artis zee system may lose coolant due to a possible leakage in a hose of the cooling unit in the X-ray tube. This will cause the X-ray tube not to be sufficiently cooled down. As a result, the system will display a message Tube hot, have a break . The X-ray will be blocked several minutes later and to prevent any damage to the machine the following message will be displayed NO XRAY, TUBE TOO HOT . This issue is very sporadic and may occur during an ongoing clinical procedure. Use of this product may have a potential impact on planned procedures as they may be delayed as well as in emergent cases, as clinical treatment may need to be terminated and transferred to a functioning system.
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-0558-2019. 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.