PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: December 10, 2014 Initiated: September 11, 2013 #Z-0486-2015

Product Description

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.

Reason for Recall

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

Details

Units Affected
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, 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.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 1131.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 10, 2014. Severity: Moderate. Recall number: Z-0486-2015.

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