Oct

2013

Cl ll Monaco RTP Radiation treatment planning

Company: Elekta Inc.
Date of Enforcement Report: 10/2/2013
Class ll:

PRODUCT

Monaco RTP System Radiation treatment planning
Recall Number Z-2276-2013

REASON
Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values.

RECALLING FIRM/MANUFACTURER
Elekta, Inc, Atlanta, GA on 7/2/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
45

DISTRIBUTION
Nationwide

___________________________________

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 ll Monaco RTP Radiation treatment planning

Amy Sellers

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