Device product
ARTIS Q.zen biplane with Material 10848355 - 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.
Z-0459-2019
Product summary
- Event
- Event 81514
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15
- Official record key
device-enforcement:Z-0459-2019
Official wording
Reason: 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
Code information: Serial Numbers: Serial 123202 123211 123208 123209 123206 123207 123219 123205 123201 123055 123056 123216 123200 123212
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
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