Events

Recall of Diagnostics Ultrasound System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Konica Minolta, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77712
  • Event Risk Class
    Class 2
  • Event Number
    Z-2769-2017
  • Event Initiated Date
    2017-04-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-01-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157692
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • Reason
    The doppler velocity measurement on the sonimage hs1 ultrasound system is not accurate.
  • Action
    Konica Minolta notified their customers on April 24, 2017.

Device

Diagnostics Ultrasound System
  • Model / Serial
    UDI  04560141940031 04560141944534 04560141945463 04560141946385   V1.31R02 V1.31R04 V1.31R05 V1.31R06 (V131R02 SW and later version)
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, CO, KY, FL, NJ, NY, IA TX, & WA
  • Product Description
    Diagnostics Ultrasound System || Ultrasounds System Sonimage HS1
  • Manufacturer
    Konica Minolta, Inc.

Manufacturer

Konica Minolta, Inc.
  • Manufacturer Address
    Konica Minolta, Inc., 411 Newark Pompton Tpke, Wayne NJ 07470-6657
  • Manufacturer Parent Company (2017)
    Konica Minolta
  • Source
    USFDA