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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Hazard
- Affected units
- 36
Distribution
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