FDA recall Z-1289-2022

Canon Medical System, USA, INC. · Class II · device

Product

System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW

Reason for recall

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.

Distribution

U.S.: CA, CO, FL, NY, and WY O.U.S.: None

Key facts

Status: Ongoing
Initiation date: 2022-05-03
Report date: 2022-07-06
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tustin, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1289-2022