FDA Device recall Z-2344-2016
Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959,…
- FDA Device
- Class II
- terminated
- Published 2016-08-17
On 2016-08-17 the FDA classified a Class II recall of Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959,… by Siemens Medical Solutions Usa, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2344-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-07 |
| Published | 2016-08-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
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
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.
Identifiers
| code_info | Serial Numbers: 121185,147996,121169,105032,109190,109191,109197,109198,125100,158225,161021,154847,124083,123050,10918…Serial Numbers: 121185,147996,121169,105032,109190,109191,109197,109198,125100,158225,161021,154847,124083,123050,109187,124102,121167,125021,121163,117125,148001,158234,148010,158229,121171, 109183,109181,131101,158226,109194,117124,158244,109179,158238,109188,121179,137714,121168,158246,161022,121175,121173,154859,109186,158230,123046,158227,109189,123052,105029,105030 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2344-2016%22
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