device · product 1 of 1
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.
- Recall number
- Z-2344-2016
- Initiated
- July 07, 2016
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 51 units
App-derived interpretation
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.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Inspect official wording and provenance
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.
Code information
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
Distribution pattern
Nationwide Distribution to AL,AZ,CA,CO,IA,IL,MA,MD,MI,MN,MO,NE,NJ,NY,OH,OR,PA,RI,TX,VA,WA,WI,WV