BEUDAMED
    FDA Recall Terminated

    Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886M. Ceiling Column Accessory: The CT and CTA Injector Systems employs an Articulating Arm that mounts to the Ceiling Column Accessory, which are designated as 9886S (11.25''), M (21.50''), and L (34.50''), i.e. 9886L.

    Recall: Z-0549-05 · Initiated December 3, 2004

    Recall

    Recall Number
    Z-0549-05
    Event Number
    31007
    Firm
    E-Z-EM, Inc
    FEI Number
    2411512
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 3, 2004
    Posted
    February 16, 2005
    Terminated
    August 24, 2007
    Address
    750 Summa Ave, Westbury, NY, 11590-5040

    Description

    Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886M. Ceiling Column Accessory: The CT and CTA Injector Systems employs an Articulating Arm that mounts to the Ceiling Column Accessory, which are designated as 9886S (11.25''), M (21.50''), and L (34.50''), i.e. 9886L.

    Reason

    Out of specification welding could cause the ceiling mount accessory to detach from its mounting. The firm received 1 complaint from a hospital that the injector fell off the ceiling mounting bracket and landed on the floor.

    Action

    On 12/3/04, "Urgent: Medical Device Recall" Letters (dated 12/3/04), were mailed via return receipt.

    Distribution

    Medical facilities, 1 distributor & 1 physician nationwide. There were also foreign accounts in Canada, United Kingdom, France, The Netherlands and Korea.