Recall Z-2220-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
Varian Medical Systems, Inc. Oncology Systems
Eclipse Treatment Planning System, Client software versions 8.0 through 8.6; 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
| Date | May 19, 2011 (initiated Apr 4, 2011) |
| Status | Terminated |
| Reason | An anomaly in Eclipse Treatment Planning System, versions 8.0 to 8.6, whereby Actual SSD (source surface distance) value may not correspond to the Planned SSD value after Planning Approval. |
| Root cause | Software design |
| Action | The firm, Varian Medical, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated April 4, 2011, to its customers. ***12-20-12, 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 describes the product, problem and actions to be taken. The customers were instructed to do the following: 1) Set the Planning Approved status in Eclipse (Eclipse displays both the Actual and Planned SSD values during plan approval) and verify both SSD values prior to approving the plan. 2)Verify the SSD values in the |
| Quantity | 5288 units |
| 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 |