Artis zee/ zeego — Class II medical device recall Z-2344-2016
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2016-08-17, distributed nationwide. Due to an error in the 19 Live Display, image reproduction may fail in the examination room and the potential
| Recall number | Z-2344-2016 |
|---|---|
| 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 | 2016-07-07 |
| Classified | 2016-08-05 |
| Reported by FDA | 2016-08-17 |
| Terminated | 2016-12-13 |
| Distributed | Nationwide (US) |
| Quantity | 51 units |
| Reason classes | device malfunction |
| Serial numbers | 105029, 105030, 105032, 109179, 109181, 109183, 109186, 109187, 109188, 109189, 109190, 109191, 109194, 109197, 109198, 117124, 117125, 121163, 121167, 121168, 121169, 121171, 121173, 121175, 121179 and 26 more |
| Model numbers | 10094135, 10094137, 10094139, 10094141, 10280959, 10848255, 10848281, 10848282, 10848283, 10848353 |
Product
Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848281, 10848282, 10848283, 10848353, 10848255 Artis zee / zeego 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 Artis zee / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. 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 an error in the 19 Live Display, image reproduction may fail in the examination room and the potential exists for the loss of images immediately after system startup.
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.