Oct

2016

3 CT Scanner Cl II Aquilion LB TSX-201A/2

Company: Toshiba America Medical Systems, Inc
Date of Enforcement Report 10/12/2016
Class lI:

PRODUCT

Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
Recall Number Z-0048-2017

REASON
It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.

RECALLING FIRM/MANUFACTURER
Toshiba America Medical Systems, Inc., Tustin, CA on 10/6/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
165

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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3 CT Scanner Cl II Aquilion LB TSX-201A/2

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