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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

PTW-FREIBURG: BeamAdjust Software and OCTAVIUS Detectors Recalled for Incorrect Calibration

Agency Publication Date: September 11, 2023
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Summary

PTW-FREIBURG has recalled 42 units of BeamAdjust software and associated OCTAVIUS Detectors due to a software error that generates incorrect calibration files. When using certain file types like TIFF or DICOM as a reference, the software produces flawed calibration data, which leads to inaccurate measurement results during medical radiation testing. The recall affects BeamAdjust Version 2.3.3 and OCTAVIUS Detector models 1000 and 1600. Consumers should contact the manufacturer or their healthcare provider for guidance on correcting the calibration settings.

Risk

The software defect causes the medical detector to be calibrated incorrectly, leading to inaccurate measurement results. This can result in incorrect radiation dosage calculations or verification during patient treatment planning.

What You Should Do

  1. Identify if you are using BeamAdjust software Version 2.3.3 (Ref: S080032) with UDI-DI: EPTWS0800320.
  2. Check if your software is used to calibrate any of the following devices: OCTAVIUS Detector 1600 SRS (T10056), OCTAVIUS Detector 1600 MR (T10057), OCTAVIUS Detector 1600 XDR (T10058), or OCTAVIUS Detector 1000 SRS (T10036).
  3. Verify if you have performed a relative calibration using the ArrayCal module within BeamAdjust while using a TIFF file or DICOM data set as a reference matrix.
  4. Immediately contact PTW-FREIBURG at their headquarters in Germany or through your local distributor to receive instructions on correcting the calibration files and software updates.
  5. Consult with a healthcare provider or qualified medical physicist to determine if previous measurements or calibrations have impacted clinical operations.
  6. For additional information, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Correction of calibration files and software guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: BeamAdjust software Version 2.3.3
Model / REF:
S080032
Lot Numbers:
UDI-DI: EPTWS0800320
Product: OCTAVIUS Detector 1600 SRS
Model / REF:
T10056
Lot Numbers:
UDI-DI: EPTWT100560
Product: OCTAVIUS Detector 1600 MR
Model / REF:
T10057
Lot Numbers:
UDI-DI: EPTWT100570
Product: OCTAVIUS Detector 1600 XDR
Model / REF:
T10058
Lot Numbers:
UDI-DI: EPTWT100580
Product: OCTAVIUS Detector 1000 SRS
Model / REF:
T10036
Lot Numbers:
UDI-DI: EPTWT100360

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92879
Status: Active
Manufacturer: PTW-FREIBURG
Sold By: Direct distribution
Manufactured In: Germany
Units Affected: 42 US
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.