Recall Z-0016-2016— Toshiba American Medical Systems Inc

Name: FDA recall Z-0016-2016
Creator: U.S. Food and Drug Administration
Published: 2015-05-08

Class II · Terminated

Class II FDA medical device recall by Toshiba American Medical Systems Inc, initiated 2015-05-08, terminated 2016-10-26. It names one FDA 510(k) clearance: K142465. Product: Toshiba Aquilion CT System TSX-301C. Reason: If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved..

Recalling firm: Toshiba American Medical Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2015-05-08
Terminated: 2016-10-26
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K142465 — Aquilion ONE Vision, v7.0Toshibamedical Systems Corporation·cleared 2015-03-10

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

Toshiba Aquilion CT System TSX-301C

Reason for recall

If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.

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