FDA-Device2013-02-27Class II
Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
Varian Medical Systems, Inc. Oncology Systems
Hazard
The calculation of dose dynamic plans containing different energy fields is incorrect when the Pencil Beam Convolution 11.0 algorithm (PBC 11.0) is used.
Sold states
Worldwide Distribution - USA Nationwide
Affected count
1168 units
Manufactured in
911 Hansen Way, N/A, Palo Alto, CA, United States
Products
Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0867-2013Don't want to check this manually?
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