BEUDAMED
    FDA Recall Terminated

    Ellex Solitarie Opthalmic Laser System, Model No: LP 4532 - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S.A. 5000, AUSTRALIA.

    Recall: Z-0286-2008 · Initiated June 13, 2007

    Recall

    Recall Number
    Z-0286-2008
    Event Number
    45499
    Firm
    Ellex USA
    Product Code
    HQF
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 13, 2007
    Posted
    December 20, 2007
    Terminated
    October 17, 2008
    Address
    7138 Shady Oak Road, Eden Prairie, MN, 55344

    Description

    Ellex Solitarie Opthalmic Laser System, Model No: LP 4532 - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S.A. 5000, AUSTRALIA.

    Reason

    Electric Shock from Power Supply : The power supply has a defect which can cause an electrical shock to user.

    Action

    Ellex, Inc. called each customer on 6/13/07, about the problem (defect which can cause electric shock) and advised that they would be performing modification of the power supply in the laser system and scheduling a field service visit to complete the work. Upon completion of the modification, the service technician completed the service record and left a copy with each client and informed them of the completed work. A copy of each completed service record was sent to Ellex Medical Pty. Ltd. On 9/27/07, Ellex sent a letter to all consignees, informing them that all modifications by service technicians' have been completed, and that their Solitaire LP4532 laser and/or Intregre Duo LP1RG is up to the manufacturers specifications and is in good operating order.

    Distribution

    Worldwide Distribution - USA including states of WI, PA, CO, CA, NC, NY, SC, MD, and MS, and countries of Canada and Brazil.

    Quantity

    10