BEUDAMED
    FDA Recall Terminated

    CIVCO SBRT System, REF MTSBRT001L, containing CIVCO Pro-Lok Platform, REF MTSBRT002. Firm name on label is CIVCO, Orange City, Iowa Product Usage: The recalled product is intended to support and aid in positioning a patient during radiologic and other medical procedures.

    Recall: Z-3021-2011 · Initiated December 30, 2010

    Recall

    Recall Number
    Z-3021-2011
    Event Number
    57543
    Firm
    Civco Medical Instruments Inc
    FEI Number
    1937223
    Product Code
    IXQ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 30, 2010
    Posted
    August 15, 2011
    Terminated
    June 28, 2013
    Address
    102 1st St S, Kalona, IA, 52247-9589

    Description

    CIVCO SBRT System, REF MTSBRT001L, containing CIVCO Pro-Lok Platform, REF MTSBRT002. Firm name on label is CIVCO, Orange City, Iowa Product Usage: The recalled product is intended to support and aid in positioning a patient during radiologic and other medical procedures.

    Reason

    Systems sold before December 2009 displayed a scale of 0-40cm going from left to right, while systems after December 2009 reversed this and were displayed as 40-0cm from left to right.

    Action

    CIVCO issued a "FIELD SAFETY NOTIFICATION" letter dated 12/20/2010 beginning 12/30/2010, via FedEx or UPS to distributors and customers. The notification identifies the affected device, problem, and field safety corrective action. The letter states that if customers have more than one system purchased from different time periods that they should examine their systems and assess if there is any mismatch. The recalling firm will rework the system to correct the difference and send it back to the customer. To take advantage of this correction customers are advised to contact the recalling firm within thirty days of receiving the safety notification. The letter includes a response form to be completed and returned as per instructions, to indicate that the notice has been read and understood by all operators of the equipment. The letter to distributors requested that a copy of the notification letter be forward to all customers who have received this component. For assistance contact your CIVCO insides sales representative by calling CIVCO Medical Solutions, Radiation Oncology, at 800-842-8688.

    Distribution

    Worldwide Distribution - USA ( nationwide) including the state of PA. and countries of: Canada, China, England, Israel, Italy, Japan, Korea, The Netherlands, Russia, Spain, Sweden, Switzerland and Turkey.

    Quantity

    49 systems