Device product
Diagnostics Ultrasound System Ultrasounds System Sonimage HS1
Z-2769-2017
Product summary
- Event
- Event 77712
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36 units
- Official record key
device-enforcement:Z-2769-2017
Official wording
Reason: The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.
Code information: UDI 04560141940031 04560141944534 04560141945463 04560141946385 V1.31R02 V1.31R04 V1.31R05 V1.31R06 (V131R02 SW and later version)
Distribution pattern: CA, CO, KY, FL, NJ, NY, IA TX, & WA
Derived failure modes
-
Unknown
The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.