PTW-FREIBURG recalls BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is perfor…

Recall date

June 7, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2577-2023

FDA classification

Class II

Brand / firm

PTW-FREIBURG

Sold / distributed

US Nationwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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)