Product Wiki · Recalls · U.S. FDA — Device Enforcement

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) ( — recall Z-2577-2023

U.S. FDA — Device Enforcement · Germany · 2023-06-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2577-2023
Date of alert: 2023-06-07
Country / jurisdiction: Germany
Risk level: Class II
Risk type: recall
Brand: PTW-FREIBURG
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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