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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 HS1see related information
Date Initiated by FirmDecember 04, 2017
Create DateMarch 27, 2018
Recall Status1 Terminated 3 on October 28, 2019
Recall NumberZ-1214-2018
Recall Event ID 79455
510(K)NumberK162065 
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
ProductSonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463; 2. AAEU, UDI: 04560141946385; 3. A9RR, UDI: 04560141945470
Code Information A9RP Serial Numbers (each has "A9RP-" prefix): 00002 00021 00022 00017 00016 00080 00029 00030 00019 00023 00008 00024 00079 00020 00027 00003 00025 00028 00026; AAEU Serial Numbers (each has "AAEU-" prefix):00001 00016 00017 00018 00019 00020 00021 00022 00023 00024 00025 
Recalling Firm/
Manufacturer		 Konica Minolta Medical Imaging USA, Inc.
411 Newark Pompton Tpke
Wayne NJ 07470-6657
For Additional Information ContactJan 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
ActionKonica 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 Commerce30
DistributionDistributed 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 CycleTPLC 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) Database510(K)s with Product Code = IYN
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