Class 2 Device Recall ERGO

• Date Initiated by Firm: December 11, 2009
• Date Posted: June 23, 2011
• Recall Status: Terminated on April 01, 2014
• Recall Number: Z-2645-2011
• Recall Event ID: 58206
• 510(K)Number: K080601
• Product Classification: System,planning,radiation therapy treatment - Product Code MUJ
• Product: ERGO++ Stereotactic Radiation Treatment Planning System, ERGO++ Release 1.6.3 and 1.6.3.1 Product Usage: Used to create treatment plans for any cancer patient for who external beam radiation therapy has been prescribed. It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning of 3-dimensional radiation therapy.
• Code Information: ERGO++ Release 1.6.3 and 1.6.3.1
• Recalling Firm/ Manufacturer: Computerized Medical Systems Inc; 13723 Riverport Drive; Suite 100; Maryland Heights MO 63043
• For Additional Information Contact: Christopher Ivicevich; 408-380-8023
• Manufacturer Reason for Recall: ERGO Release 1.6.3 is overestimating the MU values.
• FDA Determined Cause: Software design
• Action: Computerized Medical Systems, Inc. sent an "USER NOTIFICATION" dated December 11, 2009, to all affected customers. The notice identified the product, problem and suggested a workaround to minimize the risk. The notice stated that this workaround does NOT substitute the need for regular Quality Assurance. Customers are instructed to review page 39 of user manual for further explanation of warnings. Customers were asked to complete the Notice for Customer section and return to 3D Line Medical System. This issue has been resolved in Release 1.7.0 and above. No follow-up notice will be distributed to customers. For further information please contact: CMS Software (314) 812-4460 (St Louis Office)
• Quantity in Commerce: 45
• Distribution: Nationwide distribution to medical facilities in CA, MO, NC, ND, NV, NY, OH, OK, TX, and WA. Foreign distribution was made to Brazil, Cuba, Czech Republic, France, Germany, India, Italy, Japan, Malaysia, Poland, Portugal, Serbia, and Spain.
• 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