Recall – Radiation treatment planning system software error

Company: Elekta, Inc.
Date of Enforcement Report: 2/8/2019
Class II:

PRODUCT

Monaco Radiation Treatment Planning (RTP) System

Recall Number: Z-0965-2019

REASON

If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should not.

RECALLING FIRM/MANUFACTURER

Elekta, Inc. on 2/8/2019. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
14 devices

DISTRIBUTION

US Nationwide and International

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020

To pre-register and get info on deep discounts or if you have questions, email training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.