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