FDA-Device2014-03-12Class II

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

Toshiba American Medical Systems Inc
Hazard

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.

Sold states
US Distribution including the states of: MD, WV, OH, CA, MN, IN, NY and WI.
Affected count
8 units
Manufactured in
2441 Michelle Dr, P.O. Box 2068, Tustin, CA, United States
Products
TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0972-2014

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