FDAClass IIMarch 12, 2014

TSX-301C Aquilion One recall

TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.

Why was TSX-301C Aquilion One recalled?

Toshiba America Medical Systems, Inc. initiated this recall due to the failure of the parts used in the X-ray high-voltage generator. In some cases, X-ray exposure cannot be performed.

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?

SERIAL NO.: 1CB1262006, 1DB1312033, 1DC1352070, 1DB1342060, 1DB1332049, 1DC1382081, 1DB1312027, 1DB1332045, 1DC1362073, 1CB12X2018.

Product
TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.
Recalling firm
Toshiba American Medical Systems Inc
Quantity
8 units
Distribution
US Distribution including the states of: MD, WV, OH, CA, MN, IN, NY and WI.
Recall date
March 12, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls