Recall Z-2645-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
Computerized Medical Systems Inc
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.
| Date | Jun 23, 2011 (initiated Dec 11, 2009) |
| Status | Terminated |
| Reason | ERGO Release 1.6.3 is overestimating the MU values. |
| Root 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 distri |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080601 | ERGO++ VERSION 1.7 3D Line Medical Systems S.R.L., Jun 6, 2008 |