PTW-FREIBURG Recalls
3 recalls on record · September 2, 2015 to February 28, 2024 · Medical Devices
Recalls by year
15
23
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 28, 2024Medical DevicesFDA
PTW-FREIBURG recalls Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medic
Hazard: Software: If the user excludes voxels from the Gamma calculation that are below a dose threshold (Suppress gamma calculation), the Gamma Passing Rate (GPR) calculated for individual ROIs is not correct. The GPR calculated by VERIQA overestimates the correct GPR. The evaluation can therefore show false positive results.
September 20, 2023Medical DevicesFDA
PTW-FREIBURG recalls BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is perf
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.
September 2, 2015Medical DevicesFDA
PTW-Freiburg recalls PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therap
Hazard: In some cases, especially with high dose-per-pulse-rates typical for particle (specifically proton) therapy, measuring errors can result. Individual measurement intervals can be lost that are not visible to the user when there is a high dose-per-pulse rate resulting in a too-low dose being displayed on the monitor. This could result in a radiation over-exposure.