Z-0457-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 21, 2018
- Initiation Date
- October 19, 2018
- Termination Date
- April 27, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 units
Product Description
ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system 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 includes cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee can also support the acquisition of position triggered imaging for spatial data synthesis.
Reason for Recall
Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support
Distribution Pattern
US Nationwide Distribution
Code Information
Serial Numbers: Serial 155122 155149 155151 155105 155148 154671 155126 155131 155132 155119 155121 155118 155147