FDA recall Z-2769-2017

Product

Diagnostics Ultrasound System Ultrasounds System Sonimage HS1

Reason for recall

The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.

Distribution

CA, CO, KY, FL, NJ, NY, IA TX, & WA

Key facts

Status

Terminated

Initiation date

2017-04-24

Report date

2017-08-02

Termination date

2018-01-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2769-2017