Dec

2016

Elekta Monaco RTP System Cl II

Company: Elekta, Inc.
Date of Enforcement Report 12/7/2016
Class lI:

PRODUCT

Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Recall Number Z-0660-2017

REASON
Incorrect Dose when using the reset function.

RECALLING FIRM/MANUFACTURER
Elekta, Inc., Atlanta, GA on 11/25/2016 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
671

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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