BEUDAMED
    FDA Enforcement Class II Terminated

    Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced via per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

    Recall: Z-2279-2016 · Reported August 3, 2016

    Enforcement

    Recall Number
    Z-2279-2016
    Event ID
    73985
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pentax Medical Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 3, 2016
    Initiation Date
    April 6, 2016
    Classification Date
    July 22, 2016
    Termination Date
    July 17, 2017
    Address
    3 Paragon Dr, N/A, Montvale, NJ, 07645-1782, United States

    Description

    Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced via per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

    Reason

    Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

    Code Info

    Model #'s EG-3630U, FG-38UX, EG-3630UR, FG-34UX, FG-36UX, EG-3830UT, EG-3670URK and EG-3870UTK.

    Distribution

    US Nationwide Distribution

    Quantity

    819 units