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

FDA Recall #Z-0972-2014 — Class II — December 11, 2013

Recall #Z-0972-2014 Date: December 11, 2013 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

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.

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

8 units

Distribution

US Distribution including the states of: MD, WV, OH, CA, MN, IN, NY and WI.

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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