Jan

2017

Cl II Elekta Monaco RTP System

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

PRODUCT

Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Recall Number Z-1009-2017

REASON
Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.

RECALLING FIRM/MANUFACTURER
Elekta inc., Atlanta, GA on 12/21/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
279

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 Monaco RTP System

Amy Sellers

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