FDA-Device2017-08-02Class II

Diagnostics Ultrasound System Ultrasounds System Sonimage HS1

Konica Minolta, Inc.
Hazard

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

Sold states
CA, CO, KY, FL, NJ, NY, IA TX, & WA
Affected count
36 units
Manufactured in
411 Newark Pompton Tpke, N/A, Wayne, NJ, United States
Products
Diagnostics Ultrasound System Ultrasounds System Sonimage HS1

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2769-2017

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