Company:Toshiba American Medical Systems Inc
Date of Enforcement Report:3/12/2014
Class lI:

PRODUCT

TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion One Computed Tomography X-Ray System; TSX-301B Aquilion Premium Computed Tomography X-Ray System; TSX-302A Aquilion Prime Computed Tomography X-Ray System. This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head. The Aquilion RXL has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. Recall Number Z-1113-2014

REASON
oshiba intitiated this recall because their investigation revealed that due to a problem of the X-ray output control software, the X-ray output conditions may not be set correctly. As a result, X-ray exposure under the scan conditions used for contrast study may not start..

RECALLING FIRM/MANUFACTURER
Toshiba American Medical Systems Inc., Tustin, CA. on 10/1/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
618 units

DISTRIBUTION
Nationwide

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