Device product
AArtis Q/ Q.Zen biplane Artis zee biplane Product Usage: Artis 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.
Z-0508-2018
Product summary
- Event
- Event 79039
- Status
- Terminated
- Classification
- Class II
- Quantity
- 265 units
- Official record key
device-enforcement:Z-0508-2018
Official wording
Reason: Within a specific number of Artis zee biplane and Artis Q biplane systems, a connection in the ceiling mount consisting of 12 screws may not have been attached and fastened according to quality standards. A quality inspection will be initiated to ensure all screws in the rotation unit meet quality standards.
Code information: 10094141 10848282 10848355
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Within a specific number of Artis zee biplane and Artis Q biplane systems, a connection in the ceiling mount consisting of 12 screws may not have been attached and fastened according to quality standards. A quality inspection will be initiated to ensure all screws in the rotation unit meet quality standards.