FDAJune 7, 2023device
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 Detector 1600 MR (T10057) (UDI-...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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
FDA enforcement status: Ongoing
Brands named
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Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDASoftware VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.2024-02-08
- FDASoftware BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S0800322021-08-27
- FDAPTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.2015-05-27
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