BEUDAMED
    FDA Recall Terminated

    KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manuals: PDD Telescopes, Tricam SL II, and PDD Camera Heads. Used as an optional accessory to white light cystoscopy when used in combination with the diagnostic imaging drug Cysview.

    Recall: Z-1216-2013 · Initiated August 16, 2012

    Recall

    Recall Number
    Z-1216-2013
    Event Number
    60555
    Firm
    Karl Storz Endoscopy America Inc
    FEI Number
    2020550
    Product Code
    OAY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 16, 2012
    Posted
    May 8, 2013
    Terminated
    May 8, 2013
    Address
    2151 East Grand Avenue, El Segundo, CA, 90245

    Description

    KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manuals: PDD Telescopes, Tricam SL II, and PDD Camera Heads. Used as an optional accessory to white light cystoscopy when used in combination with the diagnostic imaging drug Cysview.

    Reason

    The recall was initiated because Karl Storz has confirmed that the Photodynamic Diagnosis (PDD) D-Light C System instruction manuals have important safety-related changes.

    Action

    A Safety Alert letter, dated 8/16/12, was sent to all their customers to inform them that there is a labeling error in which important safety-related changes were made to the KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System instruction manuals. The correct Ethylene Oxide (EtO) Sterilization set point for Relative Humidity should read, =70% RH. The correction applies to the PDD Camera Head instruction manual, PDD Rigid Telescopes instruction manual, and Tricam SL II instruction manual, the three component manuals indicated for use within the KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System. The letter instructed the customers to place each of the three enclosed stickers, in the appropriate instruction manual. Customers are instructed to cover the erroneous information with the provided stickers as indicated. Customers with any questions regarding the proper use of the device, are instructed to contact Karl Storz's Technical Support Department at 800-421-0837, Ext. 5350, during office hours; or Ext. 7222, 24 hours/7 days a week for emergencies.

    Distribution

    Nationwide distribution: USA including states of: IL, CA, WV, TX, SC, WI, NY, PA, NE, NJ, MD, OH, IA, and NC.

    Quantity

    15 units