RecallRadar

FDA Device recall Z-2769-2017

Diagnostics Ultrasound System Ultrasounds System Sonimage HS1

On 2017-08-02 the FDA classified a Class II recall of Diagnostics Ultrasound System Ultrasounds System Sonimage HS1 by Konica Minolta, citing the Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2769-2017
ClassificationClass II
Statusterminated
Initiated2017-04-24
Published2017-08-02
Last updated2026-09-13 11:54 UTC
CompanyKonica Minolta
DistributionCA, CO, FL, IA, KY, NJ, NY, TX, WA

Product

Diagnostics Ultrasound System Ultrasounds System Sonimage HS1

Reason

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2769-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.