FDA-Device2022-01-19Class II
Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.
Canon Medical System, USA, INC.
Hazard
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.
Sold states
US Nationwide distribution in the states of DE, FL, LA, MT, NJ, OH, and WV.
Affected count
8
Manufactured in
2441 Michelle Dr, N/A, Tustin, CA, United States
Products
Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0492-2022Don't want to check this manually?
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