BEUDAMED
    FDA Recall Terminated

    Sonesta 6210 Fluoroscopy Procedure Table; a motorized procedure table with adjustments (via a remote control) for height, tilt, back and seat cushion position; Stille Surgical AB, Sundbybergsvagen 1A, SE-17173 Solna, Sweden

    Recall: Z-0119-2009 · Initiated August 27, 2008

    Recall

    Recall Number
    Z-0119-2009
    Event Number
    49407
    Firm
    Stille AB Gardsvagen
    FEI Number
    3003696170
    Product Code
    IXR
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    August 27, 2008
    Posted
    October 20, 2008
    Terminated
    December 10, 2010
    Address
    14 Solna Sweden

    Description

    Sonesta 6210 Fluoroscopy Procedure Table; a motorized procedure table with adjustments (via a remote control) for height, tilt, back and seat cushion position; Stille Surgical AB, Sundbybergsvagen 1A, SE-17173 Solna, Sweden

    Reason

    The table contains a battery backup, not mentioned in the User Manual, which automatically will provide power to the electrical actuators/motions in case of a power loss from the main power supply. However, if a short circuit occurs, it can result in an uncontrolled movement of the table which cannot be stopped by disconnecting the device from the main power supply, as the battery automatically w

    Action

    Stille sent Field Safety Notices dated 8/27/08 to the direct accounts, informing them that the table contains a battery backup, not mentioned in the User Manual, which automatically will provide power to the electrical actuators/motions in case of a power loss from the main power supply. However, if a short circuit occurs, it can result in an uncontrolled movement of the table which cannot be stopped by disconnecting the device from the main power supply, as the battery automatically will supply continuous power to the control box. The accounts were requested to complete and return the enclosed acknowledgement card to Stille by fax or e-mail as soon as possible and no later than 9/26/08. The accounts were advised to not further use the table in conjunction with a C-arm or any other heavy object until a service technician can permanently remove the battery from the control box according to the enclosed Service Manual Amendment No. 1. Stille will make a permanent correction to the table once it has been validated and approved. Contact Stille Surgical Inc. at 1-800-655-1614 for assistance.

    Distribution

    Nationwide and Canada

    Quantity

    114 units