PTW-FREIBURG recalls BeamAdjust software version 2.3.3 (Ref: S080032) for OCTAVIUS Detectors 1000 and 1600 models. Using this software with Tiff or DICOM files as reference may cause inaccurate measurements.
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.
PTW-FREIBURG is recalling BeamAdjust software version 2.3.3 for specific OCTAVIUS Detectors 1000 and 1600 models. This software version can produce incorrect calibration files when used with Tiff or DICOM data sets, leading to inaccurate measurement results.
The software version 2.3.3 creates incorrect calibration files when relative calibration is performed using Tiff or DICOM data sets as reference matrices. This results in inaccurate measurement outcomes for the OCTAVIUS Detectors 1000 and 1600 models.
Users of OCTAVIUS Detector 1000 SRS, 1600 SRS, 1600 MR, and 1600 XDR models with BeamAdjust software version 2.3.3 are affected. Medical professionals using these devices for imaging may be at risk of inaccurate measurements.
Check if your OCTAVIUS Detector 1000 SRS, 1600 SRS, 1600 MR, or 1600 XDR model has BeamAdjust software version 2.3.3. The software version can be identified by the UDI-DI codes listed in the recall notice.
Install the corrected BeamAdjust software version from the manufacturer to ensure accurate calibration.
OCTAVIUS Detector 1000 SRS, 1600 SRS, 1600 MR, and 1600 XDR models with BeamAdjust software version 2.3.3.
Using this software version with Tiff or DICOM files as reference matrices creates incorrect calibration files, leading to inaccurate measurement results.
Check your device's UDI-DI code, which should match the codes listed in the recall notice (e.g., EPTWT100560 for OCTAVIUS 1600 SRS).
We’ve drafted a message you can send PTW-FREIBURG to request your refund or repair — edit it as you like.
Subject: Recall Z-2577-2023 — PTW-FREIBURG PTW-FREIBURG Hello, I own a PTW-FREIBURG that is covered by recall Z-2577-2023 from PTW-FREIBURG. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
