Toshiba American Medical Systems Inc: Medical Device Recall in 2012 - (Recall #: Z-2468-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display. This device is intended to produce cross sectional volume sets of the anatomy. Additionally the system, when used by a trained professional, is capable of proving data for dynamic and perfusion studies of organs and extremities.

Product Classification:

Class II

Date Initiated: May 13, 2008

Date Posted: October 3, 2012

Recall Number: Z-2468-2012

Event ID: 63166

Reason for Recall:

The SureStart function may not operate in the usual manner, and you may obtain abnormal analysis results when using the cerebral blood flow analysis function.

Status: Terminated

Product Quantity: 3 units

Code Information:

Item number TSX-301 A/2D Serial Numbers: 2DA0792004, 2DA07X2005, 2DA07Y2010, 2DA0792002, 2DA07X2008, 2DA0842023.

Distribution Pattern:

Nationwide distribution: USA including states of: MA, MD, and NV.

Voluntary or Mandated:

Voluntary: Firm initiated