Recall Z-2577-2023 ยท IYE Accelerator, Linear, Medical
PTW-FREIBURG
BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using ArrayCal (module from BeamAdjust S080032, UDI-DI: EPTWS0800320 ): " OCTAVIUS Detector 1600 SRS (T10056) (UDI-DI: EPTWT100560) " OCTAVIUS Detector 1600 MR (T10057) (UDI-DI: EPTWT100570) " OCTAVIUS Detector 1600 XDR (T10058) (UDI-DI: EPTWT100580) " OCTAVIUS Detector 10
| Date | Sep 11, 2023 (initiated Jun 7, 2023) |
| Status | Open, Classified |
| Reason | Generated calibration file will not be correct in case of a relative calibration of an OCTAVIUS Detector 1000 or OCTAVIUS Detector 1600, if a Tiff file or a DICOM data set is used as reference matrix. Therefore, the measurement result will be incorrect by using such a calibration file. |
| Root cause | Under Investigation by firm |
| Action | PTW North America notified US End users via email and attached Urgent Medical Device Correction letter from PTW Freiberg on 8/23/23. Letter states reason for recall, health risk and action to take: PTW does not recommend performing a relative calibration of the OD 1000 and OD 1600 using Tiff files and DICOM data sets and recommends using alternative reference matrices. A correct result can also be generated if the reference matrix for relative calibration is rotated 90 counterclockwise in VeriSoft and saved before loading into ArrayCal. The information mentioned above should be observed by t |
| Quantity | 42 US |
| Distribution | US Nationwide distribution. |
| 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 |