BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported September 20, 2023

    Enforcement

    Recall Number
    Z-2577-2023
    Event ID
    92879
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    PTW-FREIBURG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 20, 2023
    Initiation Date
    June 7, 2023
    Classification Date
    September 11, 2023
    Address
    Lorracher Str. 7, Freiburg Im Breisgau, N/A, Germany

    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.

    Code Info

    UDI-DI: EPTWS0800320 BeamAdjust All software Versions

    Distribution

    US Nationwide distribution.

    Quantity

    42 US