Device product
Artis Q, Angiographic x-ray system Product Usage: The Artis systems are 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 / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee / zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
Z-0601-2017
Product summary
- Event
- Event 75606
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,657 systems (worldwide)
- Official record key
device-enforcement:Z-0601-2017
Official wording
Reason: The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.
Code information: Model Numbers: 10848280, 10848281, 10848282, 10848283, 10848353, 10848354, 10848355
Distribution pattern: US Nationwide Distribution.
Derived failure modes
-
Unknown
The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.