Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation.
Reported: January 1, 2014 Initiated: November 18, 2013 #Z-0552-2014
Product Description
Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation.
Reason for Recall
An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a dose relevant parameter is changed and "do no clear MUs and Reference Point dose" is selected, the Monitor units may change.
Details
- Recalling Firm
- Varian Medical Systems, Inc.
- Units Affected
- 6701
- Distribution
- Worldwide Distribution.
- Location
- Palo Alto, CA
Frequently Asked Questions
What product was recalled? ▼
Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation.. Recalled by Varian Medical Systems, Inc.. Units affected: 6701.
Why was this product recalled? ▼
An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a dose relevant parameter is changed and "do no clear MUs and Reference Point dose" is selected, the Monitor units may change.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 1, 2014. Severity: Moderate. Recall number: Z-0552-2014.
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