ProductGuru Recalls

Official recall record

BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using ArrayCal

US FDA — Medical Devices · 2023-06-07 · GermanyClass II
Issuing authority
US FDA — Medical Devices
Recall initiated by firm
2023-06-07
Country of alert
Germany
Alert level
Class II
Alert type
recall
Brand on record
PTW-FREIBURG

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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