Z-2769-2017Class II

Diagnostics Ultrasound System Ultrasounds System Sonimage HS1

Name: Z-2769-2017 Diagnostics Ultrasound System Ultrasounds System Sonimage HS1
Creator: Konica Minolta, Inc.
Published: 2017-04-24
License: https://open.fda.gov/license/

Konica Minolta, Inc. / initiated 2017-04-24 / Terminated / root cause: software

FDA source

Konica Minolta, Inc. began a recall of Diagnostics Ultrasound System Ultrasounds System Sonimage HS1 on 2017-04-24. FDA classified it as Class II and gives the reason as "The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2769-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-24
Posted: 2017-07-26
Terminated: 2018-01-24
Recalling firm: Konica Minolta, Inc.
Product: Diagnostics Ultrasound System Ultrasounds System Sonimage HS1
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.
Root cause tag: software
FDA root cause: 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
Product codes and lots: UDI 04560141940031 04560141944534 04560141945463 04560141946385 V1.31R02 V1.31R04 V1.31R05 V1.31R06 (V131R02 SW and later version)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2769-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2769-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-02	2017-07-26

Product code IYN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)