BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1289-2022 · Initiated May 3, 2022

    Recall

    Recall Number
    Z-1289-2022
    Event Number
    90246
    Firm
    Canon Medical System, USA, INC.
    FEI Number
    2020563
    Product Code
    OWB
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    May 3, 2022
    Posted
    June 24, 2022
    Address
    2441 Michelle Dr, Tustin, CA, 92780-7047

    Description

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

    Reason

    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.

    Action

    On or about 04/20/2022, Canon Medical Systems USA, Inc sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter informing customer of a potential issue with your ALPHENIX System when used in combination with a CT system where the CT operations may be restricted by an interlock which is a result of an error "H29 M. Net error. The Error message(s) Gantry reached inner limit or Gantry reached out limit may be seen on the CT System at the time of occurence. The CT system may stop operating properly after an attempt to cancel the error message has been initiated. The error may result in the patient needing to be moved to another system for a repeat scan, which could cause a delay in diagnosis or decrease comfort for the patient. Customers are being informed that the Recalling Firm has developed a software update that will be installed by a representative of Canon Medical Systems USA that should correct the issue/situation. Prior to the install of the software update, the Urgent customer letter provides a Error resetting (workaround) as follows: 1. Hold down the Anatomical angle control selection button and the Override button on the tableside console or the satellite console (option) simultaneously for at least 1 second. 2. Repeat a second time. This should resolve the error on the CT system. For questions, contact Gary Becker, Regulatory Affairs Manager at 800-421-1968 or email [email protected] or the Canon Service Representative at 800-521-1968

    Distribution

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

    Quantity

    6 systems