Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.
FDA device recall Z-0990-2017 · posted 2017-01-10 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc.
- Reason for recall
- 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.
- Action taken
- 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 Regional Manager. This notice has been provided to the appropriate Regulatory Authorities. For further questions please call (650) 424-6833. Varian Oncology Help Desk Contact Information: Phone: +1.888.827.4265 Email: support @varian.com
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 42 devices are affected
- Distribution
- US Distribution to the states of : NJ, TN. OR and FL.
- Date initiated
- 2016-12-02
- Date posted
- 2017-01-10
- Date terminated
- 2017-05-12
- Location
- Palo Alto, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ECLIPSE TREATMENT PLANNING SYSTEM (K141283) | Varian Medical Systems, Inc. | 2014-08-07 |