Reported Sep 20, 2023 · Ongoing
BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is…
Ptw-Freiburg
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PTW-FREIBURG · Lorracher Str. 7 · Freiburg Im Breisgau · N/A
Is this the product you have?
4 of 4 products
| Model / number | Product as published |
|---|---|
(T10056) | Detector 1600 SRS |
(T10057) | Detector 1600 MR |
(T10058) | Detector 1600 XDR |
(T10036) | Detector 1000 SRS |
- Lot codes and dates
- UDI-DIEPTWS0800320 BeamAdjust All software Versions
- Amount recalled
- 42 US
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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