Artis zee/ zeego systems — Class II medical device recall Z-2404-2015
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2015-08-26, distributed nationwide. in case a system error occurs and the system enters the "Bypass Fluoro" mode while the X-ray locking function
| Recall number | Z-2404-2015 |
|---|---|
| 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 | 2015-06-30 |
| Classified | 2015-08-18 |
| Reported by FDA | 2015-08-26 |
| Terminated | 2016-12-05 |
| Distributed | Nationwide (US) |
| Quantity | 586 |
| Serial numbers | 135102, 135109, 135111, 135112, 135114, 135122, 135124, 135125, 135133, 135144, 135145, 135179, 135182, 135203, 135233, 135235, 135253, 135286, 135302, 135353, 135388, 135404, 135413, 135723, 135757 and 475 more |
Product
Artis zee/ zeego systems; 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
in case a system error occurs and the system enters the "Bypass Fluoro" mode while the X-ray locking function is active, the only way to exit the X-ray locking function, would be to either resolve the root cause of the system being in "Bypass Fluoro" or to restart the 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-2404-2015. 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.