BEUDAMED
    FDA Enforcement Class II Terminated

    Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults.

    Recall: Z-1615-2018 · Reported May 9, 2018

    Enforcement

    Recall Number
    Z-1615-2018
    Event ID
    79830
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    IntroMedic Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    May 9, 2018
    Initiation Date
    February 15, 2017
    Classification Date
    May 3, 2018
    Termination Date
    August 8, 2018
    Address
    F-Rtek 6 Floor, 11-25 Simindaero327beon-Gil; Dongan, Anyang, N/A, N/A, Korea (the Republic of)

    Description

    Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults.

    Reason

    When a user switches on MR1100 Receiver, even though the battery was fully charged, the LED was displayed as orange color due to momentary drop of battery voltage.

    Code Info

    None

    Distribution

    Us Nationwide Distribution in the states of: NY, MD, TX, IL, IN, KY, FL, OH, TN, CA, GA, KS, MO & NC

    Quantity

    82