BEUDAMED
    FDA Enforcement Class II Terminated

    Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (Interventional Angiography System), to position patient during diagnostic and interventional x-ray angiography.

    Recall: Z-0360-2020 · Reported November 20, 2019

    Enforcement

    Recall Number
    Z-0360-2020
    Event ID
    84135
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Canon Medical System, USA, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 20, 2019
    Initiation Date
    February 8, 2019
    Classification Date
    November 12, 2019
    Termination Date
    June 7, 2022
    Address
    2441 Michelle Dr, N/A, Tustin, CA, 92780-7047, United States

    Description

    Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (Interventional Angiography System), to position patient during diagnostic and interventional x-ray angiography.

    Reason

    Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit.

    Code Info

    Model CAT-870B D053991 Serial No. Manufacture Date 99D08X2101 October 2008 99D0582039 August 2005 99D0762072 June 2007 99D0852090 May 2008 99D07Y2078 November 2007 99D0812081 January 2008 99D0582042 August 2005 99D0552033 May 2005 D551206 May 2005

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AL, CT, FL, IL, OR, PA, and TX; and country of Netherlands.

    Quantity

    9 systems