Recall Z-2308-2008 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Oncology Systems
Varian Medical Systems Eclipse device, model H48, Version 6.5 is used to plan photon and electron radiation therapy treatments.
| Date | Sep 17, 2008 (initiated Jun 11, 2008) |
| Status | Terminated |
| Reason | Software anomaly in which swapping IDs of planning fields can produce inconsistencies between dose matrix and field parameters. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 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, Greece, Guadeloupe, Hong Kong, India, Israel, Iran, Italy, Ireland, Japan, Kozak, Latvia, Lebanon, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010975 | ECLIPSE 6.5 Varian Medical Systems, Inc., May 2, 2001 |