Z-0508-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2018
- Initiation Date
- August 24, 2017
- Termination Date
- August 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 265 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Nationwide Distribution
Code Information
10094141 10848282 10848355