BEUDAMED
    FDA Recall Terminated

    Precise Treatment Table Intended as a universal patient treatment support and positioning table for radiation therapy and simulation use.

    Recall: Z-1432-2010 · Initiated January 11, 2007

    Recall

    Recall Number
    Z-1432-2010
    Event Number
    55103
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    JAI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 11, 2007
    Posted
    April 23, 2010
    Terminated
    December 28, 2010
    Address
    4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, GA, 30092-3011

    Description

    Precise Treatment Table Intended as a universal patient treatment support and positioning table for radiation therapy and simulation use.

    Reason

    In some instances, the bolts which are supplied with the table have sheared off, resulting in inability to operate the powered table.

    Action

    Mandatory Field Change Order (FCO) 528 053 "Check for zinc plated Precise Table 'Z' mechanism fixation bolts", dated 1/11/2007 was distributed to all affected customers. The Change Order identified the product, stated the reason for the FCO, and the procedure to check and resolve the problem identified.

    Distribution

    Worldwide Distribution -- USA, Puerto Rico, Argentina, Australia, Austria, Bangladesh, Belgium, Canada, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Pakistan, Peru, Poland, Russia, Serbia, Spain, Sudan, Sweden, Taiwan, Thailand, Turkey & United Kingdom.

    Quantity

    185 units