FDA-Device2022-07-06Class II
System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW
Canon Medical System, USA, INC.
Hazard
CT operation may be restricted by an interlock which is a result of an system error and the CT system may stop operating properly after an attempt to cancel the error message has been initiated.
Sold states
U.S.: CA, CO, FL, NY, and WY O.U.S.: None
Affected count
6 systems
Manufactured in
2441 Michelle Dr, Tustin, CA, United States
Products
System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1289-2022Don't want to check this manually?
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