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: EPTWS08

Hazard

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.

Details from the source

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: US Nationwide distribution. Quantity: 42 US Lot/code info: UDI-DI: EPTWS0800320 BeamAdjust All software Versions

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.