Recall Z-3002-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
Varian Medical Systems, Inc. Oncology Systems
Eclipse Treatment Planning System; Varian Medical Systems, Palo Alto, CA Product Usage: Eclipse Treatment Planning System is used to plan radiotherapy treatments for patients with malignant or benign diseases. It is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (Brachytherapy) treatments.
| Date | Aug 11, 2011 (initiated Jun 30, 2011) |
| Status | Terminated |
| Reason | In affected Eclipse versions, the treatment field energy may change from the current selection to a previous selection without use intervention and without invalidating the MU or calculated dose distribution. |
| Root cause | Software design |
| Action | Varian sent an "Urgent Medical Device Correction/Urgent Field Safety Notice" letter dated June 30, 2011 to all affected consignees. The letter identifies the affected product, problem, and actions to be taken. The letter states that Varian will contact all affected customers to apply a database configuration script to the database and is preparing a correction for Eclipse Version 10 to address the issue. A Varian representative will contact each site to schedule correction when it is available. The letter also provides RECOMMENDED USER ACTIONS to follow. The Letters go on to reiterate cau |
| Quantity | 2436 |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073020 | ECLIPSE TREATMENT PLANNING SYSTEM Varian Medical Systems, Inc., Dec 19, 2007 |