Dec

2014

Cl II TomoTherapy Treatment System

Company: TomoTherapy Incorporated.
Date of Enforcement Report 12/17/2014
Class lI:

PRODUCT

TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3) Recall Number Z-0507-2015

REASON
Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System caused by a failure to monitor the jaw position after a jaw error occurs. This may result in an incorrect jaw position during treatment, without generating system interruption.

RECALLING FIRM/MANUFACTURER
TomoTherapy Incorporated, Madison, WI 11/21/2014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
210

DISTRIBUTION
Nationwide and Internationally

___________________________________

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 TomoTherapy Treatment System

Amy Sellers

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