FDA-Device2022-01-19Class II
Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
PTW NORTH AMERICA CORPORATION
Hazard
When a measurement with a PTW detector array is performed with the software BeamAdjust 2.2 or VeriSoft 8.0, a measurement error can occur under specific conditions. This error can lead to a too-low or too-high measured absolute dose which affects patient plan verification results
Sold states
US Nationwide distribution in the state of CO.
Affected count
1 unit
Manufactured in
6 Mars Ct Rm Unit 5, N/A, Boonton, NJ, United States
Products
Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0479-2022Don't want to check this manually?
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