TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captu...
FDA Recall #Z-2468-2012 — Class II — May 13, 2008
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.
Recalling Firm
Toshiba American Medical Systems Inc — Tustin, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3 units
Distribution
Nationwide distribution: USA including states of: MA, MD, and NV.
Code Information
Item number TSX-301 A/2D Serial Numbers: 2DA0792004, 2DA07X2005, 2DA07Y2010, 2DA0792002, 2DA07X2008, 2DA0842023.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated