Toshiba American Medical Systems Inc: Medical Device Recall in 2013 - (Recall #: Z-1068-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 14, 2012

Date Posted: April 17, 2013

Recall Number: Z-1068-2013

Event ID: 64673

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.

Status: Terminated

Product Quantity: 1 unit

Code Information:

Serial No: 1CB1262006

Distribution Pattern:

Distributed in the state of MD.

Voluntary or Mandated:

Voluntary: Firm initiated