Recall Z-0990-2017 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc.
Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12] Radiology: 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 intern
| Date | Jan 10, 2017 (initiated Dec 2, 2016) |
| Status | Terminated |
| Reason | Modifications in version 13.6MR2 for Contouring, SmartAdapt, and SmartSegmentation workspaces resulted in contours not being saved consistently in Eclipse. Treatment Planning System. The issue only occurs if certain conditions are fulfilled. |
| Root cause | Device Design |
| Action | Varian Medical Systems sent an Urgent Medical Device Correction Letter dated December 5, 2016 , that were sent to all 5 affected sites on December 5, 2016 by a trackable method. Letters advised users of the issue and the specific scenario that must take place for the issue to occur. Varian is investigating the issue and will provide a correction once it is available. We sincerely apologize for any inconvenience and thank you in advance for your cooperation. If you require further clarification, please feel free to contact your local Varian Medical Systems Customer Support District or Regiona |
| Quantity | 42 devices are affected |
| Distribution | US Distribution to the states of : NJ, TN. OR and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141283 | ECLIPSE TREATMENT PLANNING SYSTEM Varian Medical Systems, Inc., Aug 7, 2014 |