03
Jun
2015

Cl II Elekta Oncentra Brachy Software

0

Company: Elekta Inc.
Date of Enforcement Report 6/3/2015
Class lI:

PRODUCT

Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. Recall Number Z-1712-2015

REASON
Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.

RECALLING FIRM/MANUFACTURER
Elekta Inc., Atlanta, GA on 5/21/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
351

DISTRIBUTION
Nationwide and Internationally

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About the author

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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