Artis zee,x-ray system, angiographic Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee systems can also support the acquisition of position triggered imaging for spatial data synthesis
FDA Recall Z-2686-2017 · Posted None
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2017-02-03
Date Terminated2017-10-24
Product Quantity97 distributed worldwide, 12 distributed in United States
Reason for Recall
Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain delivery lot and 2-focus Megalix Cat Plus tube unit.
Firm Action
CDRH approved the CAP subject to the following conditions:
1. You completed this recall as of May 6, 2017. Report any failures regarding this recall immediately to the District Recall Coordinator.
2. If this recall is expanded to include any additional consignees, models, or end users, any future customer notification letters to be sent must comply with the requirements of 21 CFR 1003.21. This includes, but is not limited to, the prescribed packaging and the statement that you will remedy the defect or bring the product into compliance at no charge.
Root Cause
Component design/selection
Distribution Pattern
Worldwide Distribution - US to AR, KS, MI, IA, IL, WI, MN, WV, OH, and NY
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.