Recall Z-3022-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
Varian Medical Systems, Inc. Oncology Systems
Eclipse Treatment Planning System, 4D Structure Merge Tool Option in Eclipse Release 8.5 -10 (Client Build 8.2.2x through 10.0.34) with 4D Planning; Model Number: H48; Reference/FSCA Identifier: CP-04931; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients
| Date | Aug 15, 2011 (initiated Jul 7, 2011) |
| Status | Terminated |
| Reason | An anomaly has been identified in the 4D Structure Merge option of certain versions of Varian's Eclipse Treatment Planning System. The treatment field energy may change from the current selection to a previous selection without user intervention and without invalidating the MU or calculated dose distribution. |
| Root cause | Software design |
| Action | Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION/FIELD SAFETY NOTICE" letter dated July 7, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to cease using the 4D Structure Merge tool option in the Eclipse until further notice. Additionally, it is recommended that customers ensure that a qualified physician reviews the accuracy and placement of all patient structures used for plan development and evaluation and to conduct standard quality assurance procedures prior to patien |
| 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 |