BEUDAMED
    FDA Recall Terminated

    Mizuho ProFx 6850 Operating Room Table, with orthopedic accessories, AC Powered, manufactured by Mizuho OSI, Union City, CA.

    Recall: Z-0924-2011 · Initiated March 30, 2010

    Recall

    Recall Number
    Z-0924-2011
    Event Number
    56859
    Firm
    Mizuho Orthopedic Systems Inc
    FEI Number
    2921578
    Product Code
    JEA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 30, 2010
    Posted
    January 20, 2011
    Terminated
    May 17, 2011
    Address
    30031 Ahern Ave, Union City, CA, 94587

    Description

    Mizuho ProFx 6850 Operating Room Table, with orthopedic accessories, AC Powered, manufactured by Mizuho OSI, Union City, CA.

    Reason

    Device component spar gear box locks up and may result in failure of push pull tube, which may result in release of breaking and impact.

    Action

    All customers will be contacted to arrange for removal and shipping arrangements. Verification will be done by the Repair and Verification instructions for the leg spars, via registered letters. *******UPDATED INFO---The firm sent another notification letter---dated 12/22/10---which states in part: "****The upgrade involves the correction of your 6850 PROfx spars (6850-2100) at your facility by a Qualified Technician. The spars shall be upgraded to remove the 6850-2123, Drive Bracket, Spar Push Rod and replace it with the 6850-2170, Drive Bracket, Spar Push Rod. Upon completion of the upgrade, the 6850-2123, Drive Bracket, Spar Push rod shall be returned to Mizuho OSI for processing.*******

    Distribution

    Worldwide Distribution -- USA & Germany.

    Quantity

    17 units