Recall Z-0479-2022 ยท IYE Accelerator, Linear, Medical
PTW NORTH AMERICA CORPORATION
Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
| Date | Aug 27, 2021 |
| Status | Terminated |
| Reason | 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 |
| Root cause | Software design |
| 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 corr |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution in the state of CO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160405 | OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D Ptw-Freiburg Physikalisch-Technische-Werkstaetten, Oct 20, 2017 |