Z-2769-2017 Class II Terminated

Recalled by Konica Minolta, Inc. — Wayne, NJ

Recall Details

Product Type
Devices
Report Date
August 2, 2017
Initiation Date
April 24, 2017
Termination Date
January 24, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
36 units

Product Description

Diagnostics Ultrasound System Ultrasounds System Sonimage HS1

Reason for Recall

The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.

Distribution Pattern

CA, CO, KY, FL, NJ, NY, IA TX, & WA

Code Information

UDI 04560141940031 04560141944534 04560141945463 04560141946385 V1.31R02 V1.31R04 V1.31R05 V1.31R06 (V131R02 SW and later version)