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PTW NORTH AMERICA CORPORATION recalls Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
Recalled January 19, 2022 · FDA recall Z-0479-2022 · PTW NORTH AMERICA
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 · FDA Class II
Units
1 unit
Sold at
US Nationwide distribution in the state of CO.
Description
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
Product
Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
Manufacturer(s)
PTW NORTH AMERICA CORPORATION
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →