FDAAugust 27, 2021device

Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032

Official recall recorded by the U.S. Food & Drug Administration.

The 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

What to do

FDA enforcement status: Terminated

Brands named

ptw north americaptwptw north

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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