Recall Z-0861-2009 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Oncology Systems
Varian Medical Systems Eclipse treatment planning system, Model Number H48, versions 6.5/7.x and Inspiration 8.0.
| Date | Feb 20, 2009 (initiated Nov 21, 2008) |
| Status | Terminated |
| Reason | Possible incorrect wedge orientation in treatment: Software labeling was issued without warning message relating to preservation of user selected values for Siemens wedge orientation, wedge limits and SAD values for Elekta machines, and collimator operating limits for Saturne Machines when the software version is upgraded. |
| Root cause | Software design |
| Action | An Urgent Device Correction product notification letter/field safetly letter dated November 21, 2008, was distributed to all affected users, with a description of the problem and user corrective action steps. The letter was also distributed to Varian Sales, Marketing and Service organizations, informing them of the issue. |
| Quantity | 516 units |
| Distribution | Worldwide Distribution: USA, Austria, Belgium, Canada, Czech Republic, Finland, France, Germany, Greece, Hungary, Italy, Ireland, Lithuania, Norway, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, Netherlands, Turkey and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010975 | ECLIPSE 6.5 Varian Medical Systems, Inc., May 2, 2001 |