Diagnostics Ultrasound System Ultrasounds System recall
Diagnostics Ultrasound System Ultrasounds System Sonimage HS1
Why was Diagnostics Ultrasound System Ultrasounds System recalled?
The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI 04560141940031 04560141944534 04560141945463 04560141946385 V1.31R02 V1.31R04 V1.31R05 V1.31R06 (V131R02 SW and later version)
- Product
- Diagnostics Ultrasound System Ultrasounds System Sonimage HS1
- Recalling firm
- Konica Minolta, Inc.
- Quantity
- 36 units
- Distribution
- CA, CO, KY, FL, NJ, NY, IA TX, & WA
- Recall date
- August 2, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)