BEUDAMED
    FDA Recall Terminated

    BV212 Mobile X-Ray System

    Recall: Z-1457-04 · Initiated July 20, 2004

    Recall

    Recall Number
    Z-1457-04
    Event Number
    29855
    Firm
    Philips Medical Systems Sales & Service Region No. America
    FEI Number
    1000524572
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 20, 2004
    Posted
    September 15, 2004
    Terminated
    February 9, 2006
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021

    Description

    BV212 Mobile X-Ray System

    Reason

    Potential for c-arm to move due to loose screws

    Action

    Beginning on 7/20/04 the firm sent a letter dated 7/19/04 via certified mail. Mailing was completed 7/27/04. The letter advises customers of the problem, advises how to determine of the screws are loose, and if so to contact Philips. The letter also advises that a respresentative will visit each consignee to inspect and correct the problem.

    Distribution

    The units are distributed to hospitals and medical centers throughout the U.S.

    Quantity

    1900 total devices (includes BV25, BV 25 Gold, BV26, BV29, BV212