BEUDAMED
    FDA Recall Terminated

    Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs

    Recall: Z-2706-2017 · Initiated February 17, 2017

    Recall

    Recall Number
    Z-2706-2017
    Event Number
    76899
    Firm
    Fujifilm Medical Systems U.S.A., Inc.
    FEI Number
    2431293
    Product Code
    FDS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 17, 2017
    Terminated
    October 3, 2018
    Address
    10 Highpoint Dr, Wayne, NJ, 07470-7431

    Description

    Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs

    Reason

    Fujifilm is recalling multiple endoscopes after a retrospective review.

    Action

    Fujifilm sent an Urgent - Medical Device Removal letter dated February 17, 2017. Customers are provided information regarding the recall and asked to complete the attached form and return to Fujifilm. Questions can be directed to sales representative. For further questions, please call (973) 709-2202.

    Distribution

    US Distribution to : AL, HI and MO

    Quantity

    4 units