Recall Z-0972-2014— Toshiba American Medical Systems Inc

Name: FDA recall Z-0972-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-11

Class II · Terminated

Class II FDA medical device recall by Toshiba American Medical Systems Inc, initiated 2013-12-11, terminated 2014-10-16. It names one FDA 510(k) clearance: K132222. Product: TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.. Reason: Toshiba America Medical Systems, Inc. initiated this recall due to the failure of the parts used in the X-ray high-voltage generator. In some cases, X-ray exposure cannot be performed..

Recalling firm: Toshiba American Medical Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2013-12-11
Terminated: 2014-10-16
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K132222 — AQUILION ONE VISION, V6.0Toshibamedical Systems Corporation·cleared 2013-11-07

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

TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.

Reason for recall

Toshiba America Medical Systems, Inc. initiated this recall due to the failure of the parts used in the X-ray high-voltage generator. In some cases, X-ray exposure cannot be performed.

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