Jan

2017

Cl II Elekta Oncentra External Beam

Company: Elekta, Inc.
Date of Enforcement Report 1/18/2017
Class lI:

PRODUCT

Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating patients with cancer.
Recall Number Z-0987-2017

REASON
Cross profile for Varian 60 degree wedge shows “horns.”

RECALLING FIRM/MANUFACTURER
Elekta inc., Atlanta, GA on 12/23/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
433

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 Elekta Oncentra External Beam

Amy Sellers

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