BEUDAMED
    FDA Recall Terminated

    MinXray P200R40 Mobile Podiatry X-Ray System, Model PM200R40 (mobile) and PW200R40 (wall mounted), MinXray, Inc., 3611 Commercial Avenue, Northbrook, Illinois 60062-1822 U.S.A.

    Recall: Z-0986-04 · Initiated June 29, 2004

    Recall

    Recall Number
    Z-0986-04
    Event Number
    29354
    Firm
    Minxray Inc
    FEI Number
    1418960
    Product Code
    DS-21
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 29, 2004
    Posted
    July 20, 2004
    Terminated
    February 7, 2005
    Address
    3611 Commercial Ave, Northbrook, IL, 60062-1822

    Description

    MinXray P200R40 Mobile Podiatry X-Ray System, Model PM200R40 (mobile) and PW200R40 (wall mounted), MinXray, Inc., 3611 Commercial Avenue, Northbrook, Illinois 60062-1822 U.S.A.

    Reason

    The x-ray units are defective under 21 CFR 1020.30(h) in that the user manual had missing or inadequate information.

    Action

    MinXray sent recall letters dated 6/29/04 to their dealer accounts via certified mail, asking them to provide the names and addresses of all end-users to whom the affected models of x-ray units were sold. MinXray will then send addenda to the original user manuals to all identified end-users via certified mail, with a letter instructing them to substitute the new Specifications pages for the original page, and adding the Cooling Curve to the manual.

    Distribution

    New York, Florida, Ohio, California, Connecticutt, Minnesota, Massachusetts, Nevada, Arkansas and Illinois.

    Quantity

    56 units