BEUDAMED
    FDA Enforcement Class II 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 · Reported May 15, 2013

    Enforcement

    Recall Number
    Z-1216-2013
    Event ID
    60555
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Karl Storz Endoscopy America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 15, 2013
    Initiation Date
    August 16, 2012
    Classification Date
    May 8, 2013
    Termination Date
    May 8, 2013
    Address
    2151 East Grand Avenue, N/A, El Segundo, CA, 90245, United States

    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.

    Code Info

    The device Instruction Manual recall, which includes: 1) Telescope, 2) Camera Head, and 3) Camera System. Serial Numbers: ZZ2008 ZZ2016 ZZ2012 ZZ2019 TY2024 ZZ2013 TY2026 TY2025 TY2028 TY2021 ZZ2007 ZZ2020 TX2036 TX2033 ZZ2017, and TX2035.

    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