PTW NORTH AMERICA CORPORATION Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

PTW US notified customer Urgent Safety Notice via email and telephone on 8/27/20. Letter states reason for recall, health risk and action to take: PTW will provide free-of-charge software updates. Users who use BeamAdjust 2.2/ VeriSoft 8.0 according to the above described application must update the software to VeriSoft 8.0.1/BeamAdjust 2.2.1 prior to further use of the software. For all other users PTW recommends using BeamAdjust 2.2.1/VeriSoft 8.0.1 too. Until the software updates are available PTW recommends avoiding the air density correction method. As a workaround, if air density correction should still be applied a manually calculated air density correction value can be entered as a kUser keeping kTP untouched (kTP =1.000 !). Please also note, machine QA measurements performed with PTW detector arrays within the PTW software MultiCheck are not affected. TW has fixed the bug in the software and provides all affected users with software updates.