Oct

2016

Elekta Monaco RTP System Cl II

Company: Elekta, Inc.
Date of Enforcement Report 10/19/2016
Class lI:

PRODUCT

Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose distribution inside patients for given treatment plan set-ups
Recall Number Z-0076-2016

REASON
PWhen creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician’s Intent Rx Dose and/or the number of fractions, and then modifies the wedge angle, the MU value is scaled incorrectly..

RECALLING FIRM/MANUFACTURER
Elekta inc., Atlanta, GA on 10/13/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
365

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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Elekta Monaco RTP System Cl II

Amy Sellers

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