BEUDAMED
    FDA Recall Terminated

    Pinhole Collimator (NDCL709A) for Digital Gamma Cameras GCA-7100A series and CGA-7200A series. Regulation Number 21 CFR 892.1200, Class 2 device, .

    Recall: Z-1059-04 · Initiated May 31, 2004

    Recall

    Recall Number
    Z-1059-04
    Event Number
    29296
    Firm
    Toshiba American Med Sys Inc
    FEI Number
    2020563
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 31, 2004
    Posted
    July 20, 2004
    Terminated
    July 13, 2005
    Address
    2441 Michelle Dr, Tustin, CA, 92781

    Description

    Pinhole Collimator (NDCL709A) for Digital Gamma Cameras GCA-7100A series and CGA-7200A series. Regulation Number 21 CFR 892.1200, Class 2 device, .

    Reason

    Pinhole collimator defective.

    Action

    Firm will be inspecting and replacing defective collimators, in addition, an advisory letter will be sent to all sites to alert to the inspection and replacement. Recall began May 31, 2004.

    Distribution

    Nationwide.

    Quantity

    40