Jan

2017

Cl II Toshiba Kalare DREX-KL80

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

___________________________________

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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Cl II Toshiba Kalare DREX-KL80

Amy Sellers

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