BEUDAMED
    FDA Recall Open, Classified

    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)

    Recall: Z-2577-2023 · Initiated June 7, 2023

    Recall

    Recall Number
    Z-2577-2023
    Event Number
    92879
    Firm
    PTW-FREIBURG Lorracher Str. 7 Freiburg Im Breisgau Germany
    FEI Number
    3007360740
    Product Code
    IYE
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 7, 2023
    Posted
    September 11, 2023

    Description

    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)

    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.

    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 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.

    Distribution

    US Nationwide distribution.

    Quantity

    42 US