BEUDAMED
    FDA Enforcement Class II Terminated

    Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic and cystic ducts.

    Recall: Z-2713-2017 · Reported July 19, 2017

    Enforcement

    Recall Number
    Z-2713-2017
    Event ID
    77308
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pentax of America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 19, 2017
    Initiation Date
    January 17, 2017
    Classification Date
    July 10, 2017
    Termination Date
    March 8, 2018
    Address
    3 Paragon Dr, Montvale, NJ, 07645-1782, United States

    Description

    Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic and cystic ducts.

    Reason

    Pentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope to determine how soiling may have occurred on the surface of the suction cylinder and under the distal cap during testing.

    Code Info

    Model Numbers: Ed-3490TK and ED-3270K

    Distribution

    Worldwide Distribution-US (Nationwide) including states of: AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, PR, TN, TX, UT, VA, WA, WI, WV, WY;. and country of: CANADA.

    Quantity

    2,015 (US - 519 (ED-3490TK) and 5 (ED-3270K); OUS - 1,491)