BEUDAMED
    FDA Recall 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 · Initiated February 8, 2019

    Recall

    Recall Number
    Z-0360-2020
    Event Number
    84135
    Firm
    Canon Medical System, USA, INC.
    FEI Number
    2020563
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    February 8, 2019
    Terminated
    June 7, 2022
    Address
    2441 Michelle Dr, Tustin, CA, 92780-7047

    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.

    Action

    On 02/08/2019, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Notification to customers via USPS return receipt mail informing them of the potential problem with the Catheterization Table (CAT-870B) may tilt without operator involvement due to accidental liquid spillage. Customers are instructed to: a. Please keep the tableside console and the x-ray detector of the support units covered with sterile caps as stated in the Caution section of the operation manual. The caps are there to prevent liquids from coming into contact with the tableside console and the x-ray detector. b. If an actual event occurs, please push the emergency switch and call your service representative. c. Please share this information with all users and reviewing radiologist as well as clinical engineering and the biomedical group at your facility. d. Please complete and return the attached form and fax it to the toll free number 877-349-3054. This form may also be sent via email to [email protected]. If customers have any questions regarding this letter, they are free to contact Regulatory Affairs Manager at (800) 421-1968 or their local Representative at (800) 521-1968.

    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