Varian brand Eclipse Release 10 with RT Chart Release 10 (Client Build 10.0.28 or Build 10.0.34), An Eclipse Treatment P
FDA device recall Z-0370-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- An anomaly has been identified with Varian Eclipse and RT Chart where adding a reference point in RT Chart and editing the field dose contributions may change the Prescribed Dose Per Fraction in Eclipse.
- Action taken
- Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION/URGENT FIELD SAFETY NOTICE" dated October 31, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Varian has corrected the issue and will contact customers to schedule installation of the corrected version of the system. Contact the Varian Oncology Help Desk at 1-888-827-4265 for questions regarding this notice. .
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MUJ
- Distribution
- Worldwide Distribution.
- Date initiated
- 2011-10-31
- Date posted
- 2012-01-11
- Date terminated
- 2014-06-06
- Location
- Palo Alto, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM (K091492) | Varian Medical Systems, Inc. | 2009-06-18 |