BEUDAMED
    FDA Recall Terminated

    Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation.

    Recall: Z-2090-2017 · Initiated May 2, 2017

    Recall

    Recall Number
    Z-2090-2017
    Event Number
    77051
    Firm
    Hitachi Medical Systems America Inc
    FEI Number
    1528028
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 2, 2017
    Terminated
    November 19, 2018
    Address
    1959 Summit Commerce Park, Twinsburg, OH, 44087-2371

    Description

    Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation.

    Reason

    The strength of the arm mounting mechanism was insufficient and had to be redesigned.

    Action

    An Urgent: Device Correction Notice was sent via overnight carrier on 5/5/17. The Notice identified the affected product and problem. The firm will replace the Monitor Arm to correct the issue at no cost to the customer. If the problem occurs, customers are to call 800-800-4925 for immediate service. Hitachi Service will update the hardware at each site. Customers can contact [email protected] with questions, comments, or requests regarding the Notice.

    Distribution

    Distributed to the states of: AZ, CA, FL, HI, IL MA, MD, ME, MN, MO, NC, NJ, NY, OH, PA, SC, TN, and TX.

    Quantity

    77