BEUDAMED
    FDA Enforcement Class II 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 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1214-2018
    Event ID
    79455
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Konica Minolta Medical Imaging USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 4, 2018
    Initiation Date
    December 4, 2017
    Classification Date
    March 27, 2018
    Termination Date
    October 28, 2019
    Address
    411 Newark Pompton Tpke, Wayne, NJ, 07470-6657, United States

    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.

    Code Info

    A9RP Serial Numbers (each has "A9RP-" prefix): 00002 00021 00022 00017 00016 00080 00029 00030 00019 00023 00008 00024 00079 00020 00027 00003 00025 00028 00026; AAEU Serial Numbers (each has "AAEU-" prefix):00001 00016 00017 00018 00019 00020 00021 00022 00023 00024 00025

    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