BEUDAMED
    FDA Recall Terminated

    Wall Mounting Plate, an accessory to the Gendex eXpert DC (REF 110-0205G1) and 765DC (REF 110-0155G1)Intraoral X-Ray Systems; Gendex Dental Systems, Des Plaines, IL USA The wall mounting plate is used to install the Master Control unit of the X-ray system to two wooden wall studs spaced at 16", or to a wall supported by steel studs.

    Recall: Z-1559-2011 · Initiated December 20, 2010

    Recall

    Recall Number
    Z-1559-2011
    Event Number
    57500
    Firm
    Gendex Dental Systems
    FEI Number
    3004115000
    Product Code
    EHD
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 20, 2010
    Posted
    March 4, 2011
    Terminated
    August 14, 2012
    Address
    901 W Oakton St, Des Plaines, IL, 60018-1843

    Description

    Wall Mounting Plate, an accessory to the Gendex eXpert DC (REF 110-0205G1) and 765DC (REF 110-0155G1)Intraoral X-Ray Systems; Gendex Dental Systems, Des Plaines, IL USA The wall mounting plate is used to install the Master Control unit of the X-ray system to two wooden wall studs spaced at 16", or to a wall supported by steel studs.

    Reason

    The X-Ray unit may break loose from the mounting plate and fall off the wall due to defects in the mounting plate.

    Action

    The firm, Gendex, sent an "URGENT MEDICAL DEVICE FIELD CORRECTION" letter dated December 20, 2010 to their customers. A revised notification letter dated January 20, 2011, was sent to the customers providing further clarification on instruction to correct the problem, as well as a template for end user notification. The letters described the product, problem and actions to be taken. The customers were instructed to contact their customers, inform them of the issue and replace the wall-mounting plate. The customers were also instructed to complete and return the attached acknowledgement form via fax to 215-997-5665 Attn: Regulatory Affairs or email to: [email protected] and contact Gendex Customer Service at 1-800-323-8029. If you have any questions or concerns, contact the Regulatory Affairs Associate at 847-364-3290 or [email protected].

    Distribution

    Worldwide distribution: USA and countries including: Australia, Canada and Germany.

    Quantity

    34 wall plates