BEUDAMED
    FDA Enforcement Class II Terminated

    Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 04560141940031

    Recall: Z-1212-2018 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1212-2018
    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: A7AP, UDI: 04560141940031

    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 "A7AP-" prefix): 00045 00041 00004 00076 00090 00016 00037 00038 00060 00059 00091 00028 00089 00080 00077 00039 00057 00040 00007 00043 00024 00071 00003 00064 00011 00052 00027 00006 00044 00042 00063 00078 00087 00047 00031 00048 00008 00068 00095 00103 00096 00098 00097 00099 00100 00101 00102 00082 00084 00092 00083 00069 00079 00061 00019 00072 00081 00051 00018 00017 00065 00055 00053 00012 00015 00073 00023 00074 00002 00075 00066 00094 00020 00070 00056 00049 00025 00085 00093 00046 00086 00022 00009 00010 00021 00013 00014 00029

    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

    88