Varian Medical Systems, Eclipse Treatment Planning System, with v client versions 7.3 (build 7.3.10), 8.0 (builds 7.5.x), 8.1 (builds 8.1.x) and 8.5( builds 8.2.x). For radiation therapy.
This recall has been terminated (originally issued April 20, 2010).
- Recall Initiated
- December 9, 2009
- Posted
- April 20, 2010
- Terminated
- February 24, 2012
- Recall Number
- Z-1412-2010
- Quantity
- 3177 unit
- Firm Location
- Palo Alto, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for misdelivery of treatment-- When preparing a treatment plan involving a split, the device may calculate excessive or insufficient monitor units for the treatment plan.
Distribution
Nationwide distribution and Mexico.
Lot / Code Info
v client versions 7.3 (build 7.3.10), 8.0 (builds 7.5.x), 8.1 (builds 8.1.x) and 8.5( builds 8.2.x), with serial numbers starting with H48.
Root Cause
Software design
Action Taken
Recall initiated on 12/09/2009. Varian issued a notification letter to its consignees, including a description and corrective action step. The firm is in the process of preparing a software fix for the issue.
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