Device product
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
Z-2686-2017
Product summary
- Event
- Event 77201
- Status
- Terminated
- Classification
- Class II
- Quantity
- 97 distributed worldwide, 12 distributed in United States
- Official record key
device-enforcement:Z-2686-2017
Official wording
Reason: 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.
Code information: Serial Numbers: 124081 124061 137662 137668 137391 148001 147871 154827 154847 153197 131101 154035
Distribution pattern: Worldwide Distribution - US to AR, KS, MI, IA, IL, WI, MN, WV, OH, and NY
Derived failure modes
-
Unknown
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.