Class 2 Device Recall SONIMAGE HS1

• Date Initiated by Firm: December 04, 2017
• Create Date: March 27, 2018
• Recall Status: Terminated on October 28, 2019
• Recall Number: Z-1213-2018
• Recall Event ID: 79455
• 510(K)Number: K152577
• Product Classification: System, imaging, pulsed doppler, ultrasonic - Product Code IYN
• Product: Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA, UDI: 04560141944534
• Code Information: Serial Numbers (each has "A8WA-" prefix): 00005 00076 00078 00079 00083 00011 00093 00036 00019 00122 00116 00117 00072 00038 00080 00115 00002 00013 00082 00010 00007 00089 00120 00121 00077 00084 00119 00146 00023 00021 00085 00112 00067 00124 00109 00107 00086 00009 00102 00104 00103 00071 00110 00028 00091 00060 00006 00008 00024 00014 00025 00081 00026 00027 00003 00075 00029 00098 00101 00097 00099 00022 00100 00087 00125 00032 00114 00073 00020 00001 00111 00088 00123 00063 00037 00030 00012 00062 00147 00118 00092 00065 00066 00113 00108
• 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: 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: 85
• 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