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.
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Contact the company
📍Recalling firmPTW-FREIBURGLorracher Str. 7 · Freiburg Im Breisgau, Germany
“PTW-FREIBURG BeamAdjust Software 2.3.3: Incorrect Calibration Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57881-ptw-freiburg-beamadjust-software-2-3-3-incorrect-calibration-results. Based on FDA recall #Z-2577-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2577-2023%22&limit=1).
The Food and Drug Administration announced on June 7, 2023, that PTW-FREIBURG is recalling BeamAdjust software Version 2.3.3 because it may generate incorrect calibration files for OCTAVIUS Detectors. This error causes measurement results to be inaccurate when using specific reference matrices.
According to the FDA, the software generates an incorrect calibration file if a relative calibration is performed using a Tiff file or DICOM data set as a reference matrix. Consequently, measurement results will be incorrect when using such a calibration file.
Context
GovInfoNow's records show PTW-FREIBURG has two other recalls on record since 2024-02-08. On 2026-08-04, the company recalled VERIQA RT MonteCarlo 3D v3 Software due to a hazard where incorrect dose delivery may occur if a bolus is omitted in treatment plans. Another recall on 2024-02-08 involved PTW-FREIBURG VERIQA Software Version 2.0/2.1, which risked false positive results by calculating incorrect Gamma Passing Rates for individual ROIs.
How to tell if you have this one
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.
Brand
PTW-FREIBURG
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Update Software
Install the corrected BeamAdjust software version from the manufacturer to ensure accurate calibration.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2577-2023 (June 7, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2577-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.