Recall Z-2542-2016— Toshiba American Medical Systems Inc

Name: FDA recall Z-2542-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-04

Class II · Terminated

Class II FDA medical device recall by Toshiba American Medical Systems Inc, initiated 2016-08-04, terminated 2017-11-17. It names 2 FDA 510(k) clearances: K143027, K143046. Product: Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200.. Reason: Toshiba American Medical Systems (TAMS) is recalling the Xario Diagnostics Ultrasound System because it may become hot because of a software error..

Recalling firm: Toshiba American Medical Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2016-08-04
Terminated: 2017-11-17
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K143027 — Xario 200, V3.0Toshibamedical Systems Corporation·cleared 2014-11-20
K143046 — Xario 100, V3.0Toshibamedical Systems Corporation·cleared 2014-11-19

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 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200.

Reason for recall

Toshiba American Medical Systems (TAMS) is recalling the Xario Diagnostics Ultrasound System because it may become hot because of a software error.

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