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U.S. Department of Health and Human Services

Class 2 Device Recall SONIMAGE HS1

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  Class 2 Device Recall SONIMAGE HS1 see related information
Date Initiated by Firm December 04, 2017
Create Date March 27, 2018
Recall Status1 Terminated 3 on October 28, 2019
Recall Number Z-1212-2018
Recall Event ID 79455
510(K)Number K142197  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 04560141940031
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 
Recalling Firm/
Manufacturer		 Konica Minolta Medical Imaging USA, Inc.
411 Newark Pompton Tpke
Wayne NJ 07470-6657
For Additional Information Contact Jan Maniscalco
800-934-1034 Ext. 1316
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = KONICA MINOLTA INC.
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