Class 2 Device Recall Monaco Radiation Treatment Planning Workstation

• Date Initiated by Firm: January 13, 2011
• Date Posted: June 20, 2011
• Recall Status: Terminated on April 02, 2014
• Recall Number: Z-2598-2011
• Recall Event ID: 57801
• 510(K)Number: K071938 K091179
• Product Classification: System, planning, radiation therapy treatment - Product Code MUJ
• Product: Monaco Radiation Treatment Planning Workstation, Monaco Release 2.03.00 and above To create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed.
• Code Information: Monaco Release 2.03.00and above
• Recalling Firm/ Manufacturer: Computerized Medical Systems Inc; 13723 Riverport Drive; Suite 100; Maryland Heights MO 63043
• For Additional Information Contact: Christopher Ivicevich; 314-993-0003
• Manufacturer Reason for Recall: Monaco: When the isocenter location is edited in the IMRT Activity screen, the shift coordinates are not updated in the IMRT Plan report.
• FDA Determined Cause: Software design
• Action: Computerized Medical Systems Inc drafted a User Notice which explains the reason for correction, the clinical impact, and the workaround method. The User Notice was sent January 13, 2011. A return postcard is included for the customer to confirm receipt of the User Notice. The firm intends for this issue to be corrected in Monaco Release 3.00 in March 2011.
• Quantity in Commerce: 137
• Distribution: Worldwide Distribution - USA (Nationwide distribution to AK, AZ, CA, CO, FL, IL, IN, MA, MI, MN, MO, NC, NM, NY, OH, OR, PA, SC, TX, VA, WA, and WI and the countries of Algeria, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Phillipines, Poland, Portugal, Singapore, Slovenia, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, and the United Kindom.
• 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