Device product
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen 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. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis
Z-3096-2017
Product summary
- Event
- Event 77908
- Status
- Terminated
- Classification
- Class II
- Quantity
- 986 units in USA
- Official record key
device-enforcement:Z-3096-2017
Official wording
Reason: Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems.
Code information: Artis zee floor MN - Serial number: 140221 140226 140406
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems.