Class 2 Device Recall Monaco

• Date Initiated by Firm: June 21, 2012
• Date Posted: July 12, 2012
• Recall Status: Terminated on April 01, 2014
• Recall Number: Z-2007-2012
• Recall Event ID: 62434
• 510(K)Number: K110730
• Product Classification: System,planning,radiation therapy treatment - Product Code MUJ
• Product: Monaco Product Usage: Planning of radiation therapy
• Code Information: Version 3.10.00 - 3.20.00, inclusive
• FEI Number: 1037831
• Recalling Firm/ Manufacturer: Elekta, Inc.; 4775 Peachtree Industrial Blvd; Bldg 300, #300; Norcross GA 30092-3011
• For Additional Information Contact: Thomas Valentine; 770-670-2548
• Manufacturer Reason for Recall: Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.
• FDA Determined Cause: Software design
• Action: Elekta sent an Important Safety Notice to affected customers. The notice identified the affected product, problem, clinical impact and actions to be taken. The notice inform customers of how the issue will be resolved and instructions to follow when it is available.
• Quantity in Commerce: 38
• Distribution: US Nationwide Distribution - including the states of: CA, CT, FL, IL, IN, KY, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

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