The Artis zee / zeego Angiography System is designed as a set of… — Class II medical device recall Z-0486-2015
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2014-12-10, distributed nationwide. There is a potential issue on running Artis systems running software VC1x software if a network problem arises
| Recall number | Z-0486-2015 |
|---|---|
| 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 | 2013-09-11 |
| Classified | 2014-11-28 |
| Reported by FDA | 2014-12-10 |
| Terminated | 2015-03-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CH, CL, CN, CO, CZ, DE, DK, EG, ES, FI, FR, GB, HK, HU, ID, IE, IL, IN, IT, JO, JP, KE, KR, MY, NL, NO, NZ, PH, PK, PL, PT, RS, SA, SE, SG, SK, TH, TR, TW, UA, VN, ZA |
| Quantity | 1,131 |
| Reason classes | software |
| Serial numbers | 135000, 135102, 135109, 135111, 135112, 135114, 135117, 135120, 135122, 135124, 135125, 135129, 135132, 135133, 135137, 135143, 135144, 135145, 135148, 135151, 135152, 135157, 135169, 135179, 135180 and 475 more |
| Model numbers | 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959 |
Product
The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.
Reason for recall
There is a potential issue on running Artis systems running software VC1x software if a network problem arises, the function cannot be deactivated again by pressing the "Block Radiation" key on the touch screen control. If this behavior occurs, the system image generation function is not available for patient examinations without switching the system off and back on again manually. This
Machine access
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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.