Medical device recalls Moderate risk

Konica Minolta, Inc. recalls Diagnostics Ultrasound System Ultrasounds System Sonimage HS1

Recall date
April 24, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2769-2017
FDA classification
Class II
Brand / firm
Konica Minolta, Inc.
Sold / distributed
CA, CO, KY, FL, NJ, NY, IA TX, & WA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Diagnostics Ultrasound System Ultrasounds System Sonimage HS1

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