Eclipse Treatment Planning System, 4D Structure Merge Tool Option in Eclipse Release 8.5 -10 (Client Build 8.2.2x throug
FDA device recall Z-3022-2011 · posted 2011-08-15 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- An anomaly has been identified in the 4D Structure Merge option of certain versions of Varian's Eclipse Treatment Planning System. The treatment field energy may change from the current selection to a previous selection without user intervention and without invalidating the MU or calculated dose distribution.
- Action taken
- Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION/FIELD SAFETY NOTICE" letter dated July 7, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to cease using the 4D Structure Merge tool option in the Eclipse until further notice. Additionally, it is recommended that customers ensure that a qualified physician reviews the accuracy and placement of all patient structures used for plan development and evaluation and to conduct standard quality assurance procedures prior to patient treatment. Customers will be contacted by a Customer Service representative when the technical correction for this issue is available. Contact your local Varian Customer Support District or Regional Manager if you have questions regarding this notice.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Distribution
- Worldwide Distribution
- Date initiated
- 2011-07-07
- Date posted
- 2011-08-15
- Date terminated
- 2014-04-04
- Location
- Palo Alto, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ECLIPSE TREATMENT PLANNING SYSTEM (K073020) | Varian Medical Systems, Inc. | 2007-12-19 |