BEUDAMED
    FDA Recall Terminated

    Bravo pH Monitoring System Receiver

    Recall: Z-0633-04 · Initiated February 6, 2004

    Recall

    Recall Number
    Z-0633-04
    Event Number
    28253
    Firm
    Medtronic Gastroenterology Urology
    FEI Number
    1000135098
    Product Code
    FGM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 6, 2004
    Posted
    July 20, 2004
    Terminated
    November 21, 2005
    Address
    4000 Lexington Ave N, Shoreview, MN, 55126-2917

    Description

    Bravo pH Monitoring System Receiver

    Reason

    The product's rear panel label could smear during use causing the serial number to be unreadible. This has the remote possibility of resulting in patient data from diagnostic tests being mixed-up or attributed to the wrong patient.

    Action

    Letters dated February 6, 2004 were sent to the consignees. Enclosed with the letter to each consignee were label sticker(s) having the serial numbers of the device(s) purchased by the consignee. The letters instruct consignees to place the enclosed stickers on the devices over the previous back panel labels if the serial number of the label matches the serial number on the device. Special instructions for devices with smeared labels include the return of devices with unreadable serial numbers.

    Distribution

    The devices were distributed nationwide in the United States and worldwide.

    Quantity

    1468 units