BeamAdjust Software (PTW-FREIBURG) – Calibration File Error (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 1000 SRS (T10036) (UDI-DI: EPTWT100360)
Brand
PTW-FREIBURG Lorracher Str. 7 Freiburg Im Breisgau Germany
Lot Codes / Batch Numbers
UDI-DI: EPTWS0800320 BeamAdjust All software Versions
Products Sold
UDI-DI: EPTWS0800320 BeamAdjust All software Versions
PTW-FREIBURG Lorracher Str. 7 Freiburg Im Breisgau Germany is recalling BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative c due to 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 fil. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 the customer. No further action is required. Pass this notice on to everyone at your facility/hospital or at another facility/hospital where the equipment is located who needs to know about it.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026