0, Cl II Toshiba Ultimax DREX-ULT80

Company: Toshiba American Medical Systems Inc
Date of Enforcement Report 1/18/2017
Class lI:

PRODUCT

Ultimax DREX-ULT80, Model No. KXO-80XM Multipurpose digital x-ray system for gastrointestinal studies, vascular studies, general radiography, and fluoroscopy
Recall Number Z-1022-2017

REASON
It has been found that the generator of the system could possibly terminate the exposure prematurely during an examination. This issue was identified due to a software problem residing in the generator firmware.

RECALLING FIRM/MANUFACTURER
Toshiba American Medical Systems Inc, Tustin, CA on 12/21/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
254 systems

DISTRIBUTION
Nationwide

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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.