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.

Recall Insight

This FDA Devices action (record #Z-0486-2015) was formally reported on December 10, 2014, with the manufacturer initiating the action on September 11, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Siemens Medical Solutions USA, Inc is listed as the recalling firm, operating out of Malvern, PA. Federal records indicate 1131 units are affected.

The documented reason for this recall is: 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 scree… Distribution data in the federal record shows the product reached: 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,G…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 12 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.