Recall Z-2780-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
Varian Medical Systems, Inc. Oncology Systems
Eclipse Treatment Planning System; Release 6.5 through 10 (build 7.3.10 through 10.0.34) Varian Medical Systems, Inc. Used to plan radiotherapy treatments for patients with Malignant or benign diseases. Plans beam irradiation with photon, electron and proton beams, as well as for internal radiation treatments.
| Date | Jul 11, 2011 (initiated May 13, 2011) |
| Status | Terminated |
| Reason | In affected Eclipse versions, user editing of the MLC Leaf positions may not automatically invalidate calculated dose distributions. |
| Root cause | Software design |
| Action | Varian Medical Systems, Inc sent a "Urgent Medical Device Correction Urgent Field Safety Notice" letter dated May 13, 2011 to all affected customers. ***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letter included the description of the product, problem and recommendations and includes the release of a service pack in the future. For additional information please contact the Varian Oncology Help Desk at 888-VARIAN5 (888- 827-4265) |
| Quantity | 10,097***12-12-12 AMENDED TO: 10664 units*** |
| Distribution | Worldwide distribution: Nationwide (USA) and the country of Canada. |
| 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 |