FDA Device

Diagnostics Ultrasound System Ultrasounds System Sonimage HS1

Hazard

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

What You Should Do

Remedy

Konica Minolta notified their customers on April 24, 2017.

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Products

Diagnostics Ultrasound System Ultrasounds System Sonimage HS1
Brand
Konica Minolta, Inc.
UPC
UDI  04560141940031 04560141944534 04560141945463 04560141946385   V1.31R02 V1.31R04 V1.31R05 V1.31R06 (V131R02 SW and later version)

Units Affected

36 units

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