PTW NORTH AMERICA CORPORATION recalls Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
- Recall date
- August 27, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0479-2022
- FDA classification
- Class II
- Brand / firm
- PTW NORTH AMERICA CORPORATION
- Sold / distributed
- US Nationwide distribution in the state of CO.
Why it was recalled
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
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
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