Recall Z-1161-2012 ยท MUJ System, Planning, Radiation Therapy Treatment
Varian Medical Systems, Inc. Oncology Systems
Eclipse Treatment Planning System, versions 7.3, 8.0, 8.1, 8.2, 8.6, 8.9 and 10.0; Model H48 Varian Medical Systems, Palo Alto, CA. Product Usage: 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 proton beams, as well as for int
| Date | Mar 6, 2012 (initiated Jan 30, 2012) |
| Status | Terminated |
| Reason | Varian has been identified an anomaly with the Eclipse Treatment Planning System where the calculated dose distribution is not updated or invalidated when a recalculation or reload is performed while the compensator or fluence editor is open. |
| Root cause | Device Design |
| Action | Varian sent an URGENT MEDICAL DEVICE CORRECTION - URGENT FIELD SAFETY NOTICE letter dated January 30, 2012 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 identified the affected product, description of problem, provide recommended user actions, and special instructions for customers outside the USA and Canada. The letter stated that this document will be posted on the customer support website: http://www.MyVarian.com. Customers were instructed to co |
| Quantity | 12,077 units ***AMENDED TO 13,527 units*** |
| Distribution | Worldwide Distribution - (USA) Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102011 | ECLIPSE TREATMENT PLANNING SYSTEM Varian Medical Systems, Inc., Sep 3, 2010 |