Recall Z-2344-2016 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
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 pat
| Date | Jul 7, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | Siemens sent an Important Customer Safety Notice dated July 7, 2016, by certified mail to customers to inform them of the corrective action they plan to take to prevent potential loss of the image display for live images in the examination room after system startup. Siemens service organization will contact each customer to arrange a date to resolve the issue with a software update of the monitor firmware via AX012/16/S. For questions regarding this recall call 610-448-6461. |
| Quantity | 51 units |
| Distribution | 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 |
| FDA record | Open on fda.gov |