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Terminated

Diagnostics Ultrasound System Ultrasounds System Sonimage HS1

FDA Recall Z-2769-2017 · Posted None

Recalling FirmKonica Minolta, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2017-04-24
Date Terminated2018-01-24
Product Quantity36 units

Reason for Recall

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

Firm Action

Konica Minolta notified their customers on April 24, 2017.

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc. · 2016-10-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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