BeamAdjust software generates incorrect calibration files for radiation detectors
BeamAdjust software Version 2.3.3 generates incorrect calibration files when using TIFF or DICOM image reference data, affecting radiation measurement accuracy in OCTAVIUS Detector systems.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall affecting radiation measurement calibration software. The defect produces incorrect calibration files when using specific reference data types (TIFF, DICOM images), directly affecting measurement accuracy in clinical radiation measurement devices. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
BeamAdjust software Version 2.3.3 is a calibration tool for OCTAVIUS Detector systems, which are radiation measurement devices used in clinical settings. The software is manufactured by PTW-FREIBURG and distributed nationwide in the US.
The defect occurs in the ArrayCal calibration module. When performing relative calibration using TIFF or DICOM image files as reference matrices, the software generates incorrect calibration files. This results in inaccurate measurements when using the affected calibration files.
Affected facilities should not use calibration files generated with TIFF or DICOM reference matrices on software Version 2.3.3. Users should contact PTW-FREIBURG for corrective software updates or guidance.
The recalled product
- Product
- 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…
- Manufacturer
- PTW-FREIBURG
- Affected units
- 42
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: EPTWS0800320 BeamAdjust All software Versions
Distribution
Distributed nationwide across the United States.
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