Device product
AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Artis 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.
Z-1150-2018
Product summary
- Event
- Event 79540
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22
- Official record key
device-enforcement:Z-1150-2018
Official wording
Reason: Certain systems may have leaking of the plastic coolant couplings, the liquid can enter into the flat panel detector leading to a failure of the detector. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
Code information: Serial Numbers: 35061 35054 34999 35098 35059 35064 35073 35071 35057 35075 35083 35018 35097 35108 35046 35048 35050 46004 35045 35004 44011 35095
Distribution pattern: US Distribution in the following U.S. states: AZ, CA, FL, IA, IL, LA, MI, NC, NJ, OH, OK, and TX.
Derived failure modes
-
Unknown
Certain systems may have leaking of the plastic coolant couplings, the liquid can enter into the flat panel detector leading to a failure of the detector. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.