Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.
Abnormal images such as horizontal stripes may be displayed and recovery may not not be possible by restarting the system. The worst case scenario is an operator who is working without a workable image may remove a catheter from the patient's blood vessel and damage the blood vessel.
US Nationwide distribution in the states of DE, FL, LA, MT, NJ, OH, and WV.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0492-2022