Sep

2016

Cl II Elekta Monaco RTP System

Company: Elekta, Inc.
Date of Enforcement Report 8/31/2016
Class lI:

PRODUCT

Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Recall Number Z-2712-2016

REASON
In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the contour is deleted on some slices and saved in the same session, it is possible that the deleted contours are still present which would not be the intent of the planner.

RECALLING FIRM/MANUFACTURER
Elekta inc., Atlanta, GA on 9/1/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
3,012 units

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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