Recall Z-2468-2012— Toshiba American Medical Systems Inc

Name: FDA recall Z-2468-2012
Creator: U.S. Food and Drug Administration
Published: 2008-05-13

Class II · Terminated

Class II FDA medical device recall by Toshiba American Medical Systems Inc, initiated 2008-05-13, terminated 2012-09-27. It names one FDA 510(k) clearance: K072606. Product: 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.. Reason: 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..

Recalling firm: Toshiba American Medical Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2008-05-13
Terminated: 2012-09-27
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K072606 — AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEMToshiba America Medical Systems, In.C·cleared 2007-10-02

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-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.

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.

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