Recall Z-0486-2015 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
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.
| Date | Dec 1, 2014 (initiated Sep 11, 2013) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Device Design |
| Action | Siemens sent an Important Customer Safety Notice in September 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If the fault described above occurs, we urgently recommend switching the system OFF manually ("System shutdown") and then back ON again. The fault cannot generally be rectified sufficiently, either by executing the "System Restart" or "Application Restart" functions. A corresponding supplement to the Operator Manual is enclosed with this letter. The problem will be solved when the next Service Update i |
| Quantity | 1131 |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico., and the countries of: United Arab Emirates, Armenia, Austria, Australia, Belgium, Bahrein ,Belarus, Switzerland, Chile, China, Colombia, Czech Republic,Germany, Denmark, Egypt, Spain, Finland, France, United Kingdom, Hong Kong, Hungar |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073290 | ARTIS ZEE AND ZEEGO Siemens Medical Solutions USA, Inc., Feb 11, 2008 |