Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 04560141940031
FDA Recall #Z-1212-2018 — Class II — December 4, 2017
Product Description
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 04560141940031
Reason for Recall
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.
Recalling Firm
Konica Minolta Medical Imaging USA, Inc. — Wayne, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
88
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.
Code Information
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.