Recall Z-0805-2016 ยท MUJ System, Planning, Radiation Therapy Treatment
Varian Medical Systems, Inc.
Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments
| Date | Feb 12, 2016 (initiated Jan 11, 2016) |
| Status | Terminated |
| Reason | When using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments for Eclipse versions 11.0, 13.0, 13.5 or 13.6, the displayed dose does not correspond to the calculated Monitor Units (MU). Potential for unintended radiation exposure. |
| Root cause | Software design |
| Action | Varian sent an Urgent Medical Device Correction letters dated January 11, 2016 to all affected customers. Letters were also sent to Varian Sales and Marketing and Service organizations to notify them of the recall. The letter identified the affected product, problem and actions to be taken. For questions customers were instructed to contact their local Varian Medical Systems Customer Support District or Regional Manager. |
| Quantity | 9499 |
| Distribution | Worldwide Distribution - US Nationwide and the countries of Albania, Guadeloupe, Norway,Algeria, Guam, Pakistan, Argentina, Guatemala, Panama,Australia, Hong Kong, Paraguay, Austria, Hungary, Peru,Azerbaijan, Iceland, Philippines, Bangladesh, India, Poland,Belgium, Indonesia ,Portugal, Belorussia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152393 | Eclipse Treatment Planning System Varian Medical Systems, Inc., Sep 18, 2015 |