Ultrasound System SONIMAGE HS1 recallZ-2769-2017 · Konica Minolta, Inc. · initiated Apr 24, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Konica Minolta, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.
FDA root cause category: Software design
What the company is doing
Konica Minolta notified their customers on April 24, 2017.
Recall details
- Recall number
- Z-2769-2017
- Status
- Terminated
- Initiated by the company
- Apr 24, 2017
- Recalling firm
- Konica Minolta, Inc.
- Quantity
- 36 units
- Product code
- IYN
- FDA submissions
- K142197, K152577, K162065
- Distribution
- CA, CO, KY, FL, NJ, NY, IA TX, & WA
Product description
Diagnostics Ultrasound System Ultrasounds System Sonimage HS1
Code information (models, lots, serial numbers)
UDI 04560141940031 04560141944534 04560141945463 04560141946385 V1.31R02 V1.31R04 V1.31R05 V1.31R06 (V131R02 SW and later version)
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Ultrasound System SONIMAGE HS1 A7APKonica Minolta, Inc. · System, Imaging, Pulsed Doppler, Ultrasonic1 recall0 reports
- Ultrasound System SONIMAGE HS1 A9RPKonica Minolta, Inc. · System, Imaging, Pulsed Doppler, Ultrasonic1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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