Recall Z-2041-2012 ยท MUJ System, Planning, Radiation Therapy Treatment
Varian Medical Systems, Inc. Oncology Systems
Varian brand Varian Eclipse Treatment Planning System for radiotherapy; 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 radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and
| Date | Jul 19, 2012 (initiated Jun 18, 2012) |
| Status | Terminated |
| Reason | Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments) where changing the prescription in a calculated VMAT or RapidArc plan may lead to Monitor Units which do not reflect the new prescription. If the dose prescription of a VMAT or RapidArc plan is changed after the initial Dose Volume Optimization, the Monitor Units and dose distribution may not reflect |
| Root cause | Software design (manufacturing process) |
| Action | The firm, VARIAN Medical Systems, sent an "URGENT MEDICAL DEVICE CORRECTION; URGENT FIELD SAFETY NOTICE" dated June 18, 2012, to all affected users. The notice described the product, problem and actions to be taken. Varian is developing a technical correction for this issue. The customers will be contacted by a Varian Customer Service representative when this correction is available to schedule its installation. If you require further clarification, please feel free to contact your local Varian Medical Systems Customer Support District or Regional Manager. In USA and Canada: 1.888.VARIAN5 ( |
| Quantity | 7113 units |
| Distribution | Worldwide distribution: USA (nationwide) and countries including of: Austria, Australia, Bahrain, Belgium, Brazil, Canada, China, Chile, Colombia, Denmark, Egypt, Finland, France,Germany, Greece, Hungary, Hong Kong, India, Indonesia, Israel, Ireland, Italy, Japan, Latvia, Malaysia, Mexico, Morocco, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.