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.
This recall has been terminated (originally issued June 23, 2011).
- Company
- Computerized Medical Systems Inc
- Recall Initiated
- December 11, 2009
- Posted
- June 23, 2011
- Terminated
- April 1, 2014
- Recall Number
- Z-2645-2011
- Quantity
- 45
- Firm Location
- Maryland Heights, MO
- Official Source
- View on FDA website ↗
Reason for Recall
ERGO Release 1.6.3 is overestimating the MU values.
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.
Lot / Code Info
ERGO++ Release 1.6.3 and 1.6.3.1
Root Cause
Software design
Action Taken
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)