Class 2 Device Recall Monaco RTP System

• Date Initiated by Firm: September 04, 2019
• Create Date: September 25, 2019
• Recall Status: Open, Classified
• Recall Number: Z-2561-2019
• Recall Event ID: 83692
• 510(K)Number: K190178
• Product Classification: System, planning, radiation therapy treatment - Product Code MUJ
• Product: Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: -contouring -image manipulation -simulation -image fusion -plan optimization -QA and plan review
• Code Information: UDI: (01)00858164002244(10) 5.50.00 (01)00858164002268(10) 5.51.00
• Recalling Firm/ Manufacturer: Elekta Inc; 13723 Riverport Dr Ste 100; Maryland Heights MO 63043-4819
• Manufacturer Reason for Recall: It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
• FDA Determined Cause: Software design
• Action: The firm notified their consignees of the issue by email on 09/04/2019. The letter explained the problem and the workaround and requested the notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed and that all appropriate personnel working with the product be advised of the content of the letter.
• Quantity in Commerce: 49 units
• Distribution: Worldwide Distribution - US Nationwide in the states of WI, OH, NY, OH, IN, IA, TX, and countries of Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, UK
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MUJ