Varian Medical Systems Eclipse treatment planning system, Model Number H48, versions 6.5/7.x and Inspiration 8.0.
FDA device recall Z-0861-2009 · posted 2009-02-20 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Oncology Systems
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 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, Switzer
- Date initiated
- 2008-11-21
- Date posted
- 2009-02-20
- Date terminated
- 2011-03-10
- Location
- Palo Alto, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ECLIPSE 6.5 (K010975) | Varian Medical Systems, Inc. | 2001-05-02 |