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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

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