Home / Recalls / PTW-FREIBURG / Z-2577-2023

Z-2577-2023 Class II Ongoing

Recalled by PTW-FREIBURG — Freiburg Im Breisgau

Recall Details

Product Type: Devices
Report Date: September 20, 2023
Initiation Date: June 7, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 42 US

Product 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 for Recall

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.

Distribution Pattern

US Nationwide distribution.

Code Information

UDI-DI: EPTWS0800320 BeamAdjust All software Versions