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