Recall Z-0370-2012 ยท MUJ System, Planning, Radiation Therapy Treatment
Varian Medical Systems, Inc. Oncology Systems
Varian brand Eclipse Release 10 with RT Chart Release 10 (Client Build 10.0.28 or Build 10.0.34), An Eclipse Treatment Planning System used with ARIA Radiation Oncology (RT Chart module), Reference/FSCA Identifier: CP-05277, Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. The Eclipse Treatment Planning System (Eclipse TPS) is used to plan
| Date | Jan 11, 2012 (initiated Oct 31, 2011) |
| Status | Terminated |
| Reason | An anomaly has been identified with Varian Eclipse and RT Chart where adding a reference point in RT Chart and editing the field dose contributions may change the Prescribed Dose Per Fraction in Eclipse. |
| Root cause | Device Design |
| Action | Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION/URGENT FIELD SAFETY NOTICE" dated October 31, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Varian has corrected the issue and will contact customers to schedule installation of the corrected version of the system. Contact the Varian Oncology Help Desk at 1-888-827-4265 for questions regarding this notice. . |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091492 | MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM Varian Medical Systems, Inc., Jun 18, 2009 |