# FDA recall Z-2577-2023

> **PTW-FREIBURG** · Class II · device recall initiated 2023-06-07.

## 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 Detector 1600 MR 	(T10057) (UDI-DI: EPTWT100570)  "	OCTAVIUS Detector 1600 XDR 	(T10058) (UDI-DI: EPTWT100580)  "	OCTAVIUS Detector 1000 SRS 	(T10036) (UDI-DI: EPTWT100360)

## Reason for recall

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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2577-2023
- **Recalling firm:** PTW-FREIBURG
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-07
- **Report date:** 2023-09-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Freiburg Im Breisgau, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2577-2023

## Citation

> AI Analytics. FDA recall Z-2577-2023. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-2577-2023. Source: US FDA. Licensed CC0.

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