Company: Toshiba American Medical Systems Inc
Date of Enforcement Report 1/18/2017
Class lI:
PRODUCT
Kalare DREX-KL80, Model No. KXO-80XD Diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations
Recall Number Z-1021-2017
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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