BEUDAMED
    FDA Recall Terminated

    Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463; 2. AAEU, UDI: 04560141946385; 3. A9RR, UDI: 04560141945470

    Recall: Z-1214-2018 · Initiated December 4, 2017

    Recall

    Recall Number
    Z-1214-2018
    Event Number
    79455
    Firm
    Konica Minolta Medical Imaging USA, Inc.
    FEI Number
    2241281
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 4, 2017
    Terminated
    October 28, 2019
    Address
    411 Newark Pompton Tpke, Wayne, NJ, 07470-6657

    Description

    Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463; 2. AAEU, UDI: 04560141946385; 3. A9RR, UDI: 04560141945470

    Reason

    There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke may be emitted from the AC Adapter as a direct result.

    Action

    Konica Minolta is preparing for the final AC Adapter replacement. Upon receipt of the new AC Adapter, owners of SONIMAGE HSl System will be asked to replace the existing AC Adapter. Additionally, instructions for the return of the current AC Adapter will be provided.

    Distribution

    Distributed in the following U.S. states: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, WA, WI and the District of Columbia. Distributed in Canada and Brazil.

    Quantity

    30