BEUDAMED
    FDA Recall Terminated

    Neuro Adapter 2 used with the Berchtold B-810 Surgical Table or Getinge USA Fortis Surgical Table Catalog No: MDTNA2

    Recall: Z-1327-04 · Initiated July 12, 2004

    Recall

    Recall Number
    Z-1327-04
    Event Number
    29589
    Firm
    Allen Medical Systems One Post Office Square
    Product Code
    FQO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 12, 2004
    Posted
    August 7, 2004
    Terminated
    May 5, 2005
    Address
    Acton, MA, 01720-3934

    Description

    Neuro Adapter 2 used with the Berchtold B-810 Surgical Table or Getinge USA Fortis Surgical Table Catalog No: MDTNA2

    Reason

    Neuro adapter may fail to engage and adequately clamp to the surgical table, resulting in movement

    Action

    Allen Medical notified the two distributors by telephone on 7/12/04 and 7/16/04. A customer notifcation letter issued requesting return of the device for correction.

    Distribution

    SC

    Quantity

    29 units