FDA-Device2014-12-10Class II
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.
Siemens Medical Solutions USA, Inc
Hazard
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
Sold states
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, Hungary, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, Kenya, Korea, Kazakhstan, Malaysia, Netherlands, Norway, New Zealand, Philippines, Pakistan, Poland, Palestina, Portugal, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Turkey, Taiwan, Ukraine, Vietnam and South Africa.
Affected count
1131
Manufactured in
51 Valley Stream Pkwy, N/A, Malvern, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0486-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief