Z-2769-2017 Class II Terminated
FDA device recall Z-2769-2017 was initiated by Konica Minolta, Inc. on April 24, 2017 and is designated Class II. Reason for recall: The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate. The recall status is terminated (terminated January 24, 2018). Affected quantity: 36 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 2, 2017
- Initiation Date
- April 24, 2017
- Termination Date
- January 24, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36 units
Product Description
Diagnostics Ultrasound System Ultrasounds System Sonimage HS1
Reason for Recall
The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.
Distribution Pattern
CA, CO, KY, FL, NJ, NY, IA TX, & WA
Code Information
UDI 04560141940031 04560141944534 04560141945463 04560141946385 V1.31R02 V1.31R04 V1.31R05 V1.31R06 (V131R02 SW and later version)