BEUDAMED
    FDA Recall Terminated

    HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04, 2.01.05, 2.01.06, 1.00.06, 1.00.07, 1.00.08, 1.00.09, 1.00.10, 1.00.11, 1.00.12

    Recall: Z-2275-2019 · Initiated July 25, 2019

    Recall

    Recall Number
    Z-2275-2019
    Event Number
    83429
    Firm
    NeuroLogica Corporation
    FEI Number
    3004938766
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 25, 2019
    Terminated
    September 11, 2020
    Address
    14 Electronics Ave, Danvers, MA, 01923-1011

    Description

    HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04, 2.01.05, 2.01.06, 1.00.06, 1.00.07, 1.00.08, 1.00.09, 1.00.10, 1.00.11, 1.00.12

    Reason

    There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size value set by the user in the Doppler Only mode.

    Action

    On July 25, 2019, Neurological Corporation a subsidiary of Samsung Electronics issued Urgent Field Safety Notices to customers. Customers were advised to the following actions: 1) If the user wants to decrease the Dopper SV (Sample Volume) size set by himself/herself in the Doppler Only Mode, the user should press "set" button to update the PW Doppler mode. 2) A copy of the Field Safety Notice should be passed on to all who need to be aware within your organization. 3) Contact your local Samsung representative if you have questions. 4) Return the completed Customer Reply Form to Tom Leinart [email protected].

    Distribution

    US Nationwide

    Quantity

    3582 worldwide