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U.S. Department of Health and Human Services

Class 2 Device Recall Diagnostics Ultrasound System

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  Class 2 Device Recall Diagnostics Ultrasound System see related information
Date Initiated by Firm April 24, 2017
Create Date July 26, 2017
Recall Status1 Terminated 3 on January 24, 2018
Recall Number Z-2769-2017
Recall Event ID 77712
510(K)Number K142197  K152577  K162065  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product Diagnostics Ultrasound System
Ultrasounds System Sonimage HS1
Code Information UDI  04560141940031 04560141944534 04560141945463 04560141946385   V1.31R02 V1.31R04 V1.31R05 V1.31R06 (V131R02 SW and later version)
Recalling Firm/
Manufacturer		 Konica Minolta, Inc.
411 Newark Pompton Tpke
Wayne NJ 07470-6657
For Additional Information Contact Ms. Jan Maniscalco
800-934-1034 Ext. 1427
Manufacturer Reason
for Recall		 The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.
FDA Determined
Cause 2		 Software design
Action Konica Minolta notified their customers on April 24, 2017.
Quantity in Commerce 36 units
Distribution CA, CO, KY, FL, NJ, NY, IA TX, & WA
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.
510(K)s with Product Code = IYN and Original Applicant = KONICA MINOLTA, INC.
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