Artis zee, Angiographic x-ray system

Recall Insight

This FDA Devices action (record #Z-1824-2017) was formally reported on April 26, 2017, with the manufacturer initiating the action on March 28, 2017. 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 3 units distributed in U.S. units are affected.

The documented reason for this recall is: Software error - As a result of a software fault in Artis zee systems with software version VD11 and an A100 generator, the possibility exists that following the failure of a tube assembly focus, the Artis system functi… Distribution data in the federal record shows the product reached: Distributed to: VA, CA, WI. 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 9 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.