Oct

2017

Toshiba Medical Kalare Fluoroscopic X-Ray Cl II

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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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Toshiba Medical Kalare Fluoroscopic X-Ray Cl II

Amy Sellers

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