FDA recall Z-2712-2017

Product

APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 diagnostic ultrasound system

Reason for recall

When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.

Distribution

Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2017-05-01

Report date

2017-07-19

Termination date

2023-10-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tustin, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2712-2017