BEUDAMED
    FDA Enforcement Class II Terminated

    Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588

    Recall: Z-1215-2018 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1215-2018
    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: A8AR, UDI: 04560141941588

    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

    Serial Numbers (each has "A8AR-" prefix): 00068 00031 00062 00066 00063 00047 00065 00032 00064 00028 00069 00060 00027 00067 00061 00001 00002

    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

    17