BEUDAMED
    FDA Enforcement Class II Terminated

    Video Cystoscope models ECY-1570 and ECY-1570K

    Recall: Z-0615-2018 · Reported February 21, 2018

    Enforcement

    Recall Number
    Z-0615-2018
    Event ID
    79131
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pentax of America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 21, 2018
    Initiation Date
    July 13, 2017
    Classification Date
    February 14, 2018
    Termination Date
    July 22, 2019
    Address
    3 Paragon Dr, Montvale, NJ, 07645-1782, United States

    Description

    Video Cystoscope models ECY-1570 and ECY-1570K

    Reason

    The video cytoscopes lack 510(k) premarket notification clearance.

    Code Info

    Serial number: J110097 J110101 G110053 G110051 G110052 G110054 G110015 G110084 H110086 H110088 J110062 G110016 G110039 G110048 G110049 G110038 J110061 G110021 J110078 G110056 G110057 G110073 G110037 G110058

    Distribution

    Distributed in 8 states: CA, IL, MD, MI, ND, NH, NY, SD, and Guam.

    Quantity

    24