CLASS II ONGOING Device recall · Reported 20 Sep 2023 · FDA Enforcement Report
BeamAdjust software Version 2.3.3 Ref: S080032 The following devices recalled
Ptw-freiburg is recalling BeamAdjust software Version 2.3.3 Ref: S080032 The following devices, distributed nationwide in the US. The recall was initiated on 7 Jun 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2577-2023
- FDA event ID
- 92879
- Recalling firm
- Ptw-freiburg, Freiburg Im Breisgau
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Jun 2023
- FDA classified
- 11 Sep 2023
- Reported
- 20 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 7 Jun 2023 | Recall initiated by company | |
| 11 Sep 2023 | Classified by FDA | +96 days |
| 20 Sep 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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)
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI-DI: EPTWS0800320 BeamAdjust All software Versions
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ptw-freiburg
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Veriqa RT MonteCarlo 3D v3 recalled by PTW Freiburg | PTW Freiburg | Device Malfunction | Nationwide |
| Device | CLASS II | Software Veriqa (S070031), version 2.0 and 2.1- Software package recalled | Ptw-freiburg | Device Malfunction | GA |
| Device | CLASS II | PTW Unidos webline recalled by PTW-Freiburg | Ptw-Freiburg | Other | 10 states |
Other Medical Software recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Volara System Volara, HC, NA recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Enterprise Archive V8 recalled by GE Healthcare | GE Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Veriqa RT MonteCarlo 3D v3 recalled by PTW Freiburg | PTW Freiburg | Device Malfunction | Nationwide |
| Device | CLASS II | Centricity Enterprise Archive V2, V3, and V4 recalled by GE Healthcare | GE Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Et Control recalled by Datex-Ohmeda | Datex-Ohmeda | Device Malfunction | Nationwide |