Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
Recall
- Recall Number
- Z-0479-2022
- Event Number
- 89314
- Firm
- PTW NORTH AMERICA CORPORATION
- FEI Number
- 3019665367
- Product Code
- IYE
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- August 27, 2021
- Terminated
- February 9, 2024
- Address
- 6 Mars Ct, Rm Unit 5, Boonton, NJ, 07005-9309
Description
Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
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
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.
US Nationwide distribution in the state of CO.
1 unit