Recall Z-0552-2014 ยท MUJ System, Planning, Radiation Therapy Treatment
Varian Medical Systems, Inc.
Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation.
| Date | Dec 20, 2013 (initiated Nov 18, 2013) |
| Status | Terminated |
| Reason | An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a dose relevant parameter is changed and "do no clear MUs and Reference Point dose" is selected, the Monitor units may change. |
| Root cause | Software design |
| Action | Varian Medical Systems will provide all affected consignees with an Urgent Medical Device Correction Letter commencing on November 18, 2013 by federal express. . The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the reported issue. |
| Quantity | 6701 |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |