BeamAdjust software Version 2.3.3 recall
BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using ArrayCal (module from…
Why was BeamAdjust software Version 2.3.3 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: EPTWS0800320 BeamAdjust All software Versions
- Product
- BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using ArrayCal (module from…
- Recalling firm
- PTW-FREIBURG
- Quantity
- 42 US
- Distribution
- US Nationwide distribution.
- Recall date
- September 20, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)