Varian Medical Systems Eclipse device, model H48, Version 6.5 is used to plan photon and electron radiation therapy trea
FDA device recall Z-2308-2008 · posted 2008-09-17 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Oncology Systems
- Reason for recall
- Software anomaly in which swapping IDs of planning fields can produce inconsistencies between dose matrix and field parameters.
- Action taken
- Recall initiated June 11, 2008 when the firm issued an Urgent Device Correction recall letter. The letter was distributed to all affected users, with problem description and user corrective action steps. If you have questions, contact your local Varian Customer Support Representative.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 907 units
- Distribution
- Product was distributed throughout the USA and to Argentina, Australia, Austria, Belgium, Byelorussia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Ecuador, Egypt, Finland, France, Germany,
- Date initiated
- 2008-06-11
- Date posted
- 2008-09-17
- Date terminated
- 2011-03-10
- Location
- Palo Alto, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ECLIPSE 6.5 (K010975) | Varian Medical Systems, Inc. | 2001-05-02 |