Z-2577-2023Class II

BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration...

Name: Z-2577-2023 BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration...
Creator: Ptw-Freiburg
Published: 2023-06-07
License: https://open.fda.gov/license/

PTW-Freiburg / initiated 2023-06-07 / Open, Classified / root cause: manufacturing process

FDA source

PTW-FREIBURG began a recall of BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using ArrayCal (module from... on 2023-06-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2577-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-07
Posted: 2023-09-11
Recalling firm: PTW-Freiburg
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)
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: PTW North America notified US End users via email and attached Urgent Medical Device Correction letter from PTW Freiberg on 8/23/23. Letter states reason for recall, health risk and action to take: PTW does not recommend performing a relative calibration of the OD 1000 and OD 1600 using Tiff files and DICOM data sets and recommends using alternative reference matrices. A correct result can also be generated if the reference matrix for relative calibration is rotated 90 counterclockwise in VeriSoft and saved before loading into ArrayCal. The information mentioned above should be observed by the customer. No further action is required. Pass this notice on to everyone at your facility/hospital or at another facility/hospital where the equipment is located who needs to know about it.
Quantity in commerce: 42 US
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI: EPTWS0800320 BeamAdjust All software Versions

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2577-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2577-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-20	2023-09-11

Product code IYE

K160405Class IIOctavius I, Octavius II, Octavius III, Octavius 4DPtw-Freiburg Physikalisch-Technische-Werkstaetten / cleared 2017-10-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)