ClearanceBrief
Recall Z-2769-2017 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic

Konica Minolta, Inc.

Diagnostics Ultrasound System Ultrasounds System Sonimage HS1

DateApr 24, 2017
StatusTerminated
ReasonThe Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.
Root causeSoftware design
ActionKonica Minolta notified their customers on April 24, 2017.
Quantity36 units
DistributionCA, CO, KY, FL, NJ, NY, IA TX, & WA
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K142197ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2
Konica Minolta, Inc., Nov 21, 2014
K152577ULTRASOUND SYSTEM SONIMAGE HS 1
Konica Minolta, Inc., Oct 8, 2015
K162065Ultrasound System SONIMAGE HS1
Konica Minolta, Inc., Oct 19, 2016