Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
FDA Recall Z-0479-2022 · Posted None
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Recalling FirmPTW NORTH AMERICA CORPORATION
Recall StatusTerminated
Product CodeIYE
Date Initiated2021-08-27
Date Terminated2024-02-09
Product Quantity1 unit
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
Firm Action
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.
Root Cause
Software design
Distribution Pattern
US Nationwide distribution in the state of CO.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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