BEUDAMED
    FDA Enforcement Class II Terminated

    VS300 radiographic Cassette Holder or Wall Stand. For use in radiology department.

    Recall: Z-0762-2016 · Reported February 17, 2016

    Enforcement

    Recall Number
    Z-0762-2016
    Event ID
    72798
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Del Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 17, 2016
    Initiation Date
    December 3, 2015
    Classification Date
    February 5, 2016
    Termination Date
    January 26, 2018
    Address
    241 Covington Dr, N/A, Bloomingdale, IL, 60108-3109, United States

    Description

    VS300 radiographic Cassette Holder or Wall Stand. For use in radiology department.

    Reason

    The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient.

    Code Info

    Product # Serial # 110-5124G1 , 00019-0114 110-5124G1 , 00020-0114 110-5124G1 , 00092-0114 110-5124G1 , 00551-0314 110-5124G1 , 00512-0214 110-5124G1 , 00447-0214 110-5124G1 , 00016-0114 110-5124G1 , 00554-0314 110-5124G1 , 00094-0114 110-5124G1 , 00256-0214 110-5124G1 , 00741-0314 110-5124G1 , 00446-0214 110-5124G1 , 00017-0114 110-5124G1 , 00093-0114 110-5124G1 , 00236-0114 110-5124G1 , 00814-0414 110-5124G1 , 00815-0414 110-5124G1 , 00340-0214 110-5124G3 , 00995-0414 110-5124G1 , 00338-0214 110-5124G1 , 00552-0314 110-5124G1 , 00253-0214 110-5124G1 , 00445-0214 110-5124G1 , 00254-0214 110-5124G1 , 00095-0114 110-5124G1 , 00670-0314 110-5124G1 , 00252-0214 110-5124G1 , 00018-0114 110-5124G1 , 00669-0314 110-5124G1 , 00339-0214 110-5124G1 , 00444-0214 110-5124G1 , 00255-0214

    Distribution

    Worldwide Distribution-US (nationwide) and the countries of Canada, Costa Rica, Libya, Mexico, and Philippines.

    Quantity

    4000