Reported Aug 2, 2017 · Terminated
Diagnostics Ultrasound System Ultrasounds System Sonimage HS1
Konica Minolta, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Konica Minolta, Inc. · 411 Newark Pompton Tpke · Wayne, NJ · 07470-6657
Is this the product you have?
- Diagnostics Ultrasound System Ultrasounds System Sonimage HS1
- Lot codes and dates
- UDI(V131R02 SW and later version)
04560141940031045601419445340456014194546304560141946385V1.31R02V1.31R04V1.31R05V1.31R06
- UDI
- Amount recalled
- 36 units
Where it was sold
Why it was recalled
The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.
This product could cause temporary or reversible health problems — stop using it.
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