Varian Medical Systems, Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48, radiation therapy treat
FDA device recall Z-2231-2009 · posted 2009-09-22 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Oncology Systems
- Reason for recall
- Software Issue/Mistreatment Potential-- Due to software issues, dose distribution may be incorrect and unintended radiation doses may be delivered.
- Action taken
- Varian Medical Systems Recall initiated on July 17, 2009. A product notification letter was distributed to the affected user, with a description of the problem and user corrective action steps. The letter will be distributed to the sales, marketing and service organizations via certified mail. A software correction is planned.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 1
- Distribution
- Product was distributed to one user in Texas
- Date initiated
- 2009-07-17
- Date posted
- 2009-09-22
- Date terminated
- 2010-11-27
- Location
- Palo Alto, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM (K071873) | Varian Medical Systems, Inc. | 2007-08-09 |