Company: Elekta, Inc.
Date of Enforcement Report: 9/4/2019
Class II
PRODUCT
Monaco Radiation Treatment Planning System (RTP) System
- Recall Number: Z-2409-2019
REASON
Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions.
RECALLING FIRM/MANUFACTURER
Elekta, Inc. on 8/23/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
49 units
DISTRIBUTION
US Nationwide and International