The Recall Desk
HighFDA (Devices)·Z-2769-2017·Announced 2017-08-02

Konica Minolta Sonimage HS1 Ultrasound System Recalled for Inaccurate Doppler Measurements

Konica Minolta is recalling 36 Sonimage HS1 ultrasound systems because Doppler velocity measurements are not accurate.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a functional defect (inaccurate measurements) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Konica Minolta, Inc. is recalling 36 units of the Sonimage HS1 Diagnostics Ultrasound System. The recall is due to a defect where the Doppler velocity measurement on the system is not accurate.

The affected units were distributed in California, Colorado, Kentucky, Florida, New Jersey, New York, Iowa, Texas, and Washington. The specific software versions involved are V1.31R02, V1.31R04, V1.31R05, and V1.31R06 (V131R02 SW and later version).

Healthcare providers should stop using the affected systems and contact Konica Minolta for further instructions on remediation or replacement.

The recalled product

Product
Diagnostics Ultrasound System Ultrasounds System Sonimage HS1
Manufacturer
Konica Minolta, Inc.
Category
Medical Device — Ultrasound System
Hazard
Affected units
36

Distribution

Distributed in 9 states:

Related recalls

Same hazard · inaccurate measurement

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