Device product
AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.
Z-2525-2018
Product summary
- Event
- Event 80476
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 units US
- Official record key
device-enforcement:Z-2525-2018
Official wording
Reason: Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, which could cause a short circuit and cause the system to shut down suddenly during an ongoing procedure
Code information: Laird Cooling Unit for SSFD: Material # 7555118.
Distribution pattern: HI , IL, MI, NC, NY, VA, WI
Derived failure modes
-
Unknown
Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, which could cause a short circuit and cause the system to shut down suddenly during an ongoing procedure