Recall Z-2709-2017— Toshiba American Medical Systems Inc

Name: FDA recall Z-2709-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-01

Class II · Terminated

Class II FDA medical device recall by Toshiba American Medical Systems Inc, initiated 2017-05-01, terminated 2023-10-11. It names one FDA 510(k) clearance: K162155. Product: XARIO 200 TUS-X200 diagnostic ultrasound system. Reason: 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..

Recalling firm: Toshiba American Medical Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2017-05-01
Terminated: 2023-10-11
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K162155 — Xario 200 Diagnostic Ultrasound System V5.0Toshibamedical Systems Corporation·cleared 2016-11-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

XARIO 200 TUS-X200 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.