FDAClass IIOctober 3, 2012

TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a recall

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…

Why was TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Toshiba American Medical Systems Inc
Quantity
3 units
Distribution
Nationwide distribution: USA including states of: MA, MD, and NV.
Recall date
October 3, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls