FDA recall Z-0479-2022

PTW NORTH AMERICA CORPORATION · Class II · device

Product

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

Reason for recall

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

Distribution

US Nationwide distribution in the state of CO.

Key facts

Status: Terminated
Initiation date: 2021-08-27
Report date: 2022-01-19
Termination date: 2024-02-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Boonton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0479-2022