Company:oshiba American Medical Systems Inc
Date of Enforcement Report 10/25/2017
Class lI:

PRODUCT

Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. It is intended for use by qualified/trained doctors or technologists on both adult and pediatric subjects
Recall Number Z-0012-2018

REASON
During an examination images were displayed on the live monitor,but the images were not displayed on the system monitor nor were they saved to the hard disk.

RECALLING FIRM/MANUFACTURER
oshiba American Medical Systems Inc, Tustin, CAon 9/12/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
96

DISTRIBUTION
Nationwide

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