Recall Z-1068-2013— Toshiba American Medical Systems Inc

Name: FDA recall Z-1068-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-14

Class II · Terminated

Class II FDA medical device recall by Toshiba American Medical Systems Inc, initiated 2012-11-14, terminated 2013-04-08. It names one FDA 510(k) clearance: K122109. Product: Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.. Reason: Due to a problem with the control software of the x-ray high-voltage generator, if scanning is performed with a tube current less than 30mA, the control software may detect an error and perform error processing even though the x-ray output is normal..

Recalling firm: Toshiba American Medical Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2012-11-14
Terminated: 2013-04-08
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K122109 — AQUILION ONE VISION, V4.90Toshiba America Medical Systems, In.C·cleared 2012-09-21

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 TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.

Reason for recall

Due to a problem with the control software of the x-ray high-voltage generator, if scanning is performed with a tube current less than 30mA, the control software may detect an error and perform error processing even though the x-ray output is normal.

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