PTW-FREIBURG 2024-02-28 Health serious FDA
Health · FDA · Recall #FDA-Z-1181-2024
Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation… Recall
Issued February 28, 2024 · PTW-FREIBURG
In February 2024, PTW-FREIBURG recalled the Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Software: If the user excludes voxels from the Gamma calculation that are below a dose threshold (Suppress gamma calculation), the Gamma Passing Rate (GPR) calculated for individual ROIs is not correct. The GPR calculated by VERIQA overestimates the correct GPR. The evaluation can therefore show false positive results.
What you should do
- 1 Stop using Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact PTW-FREIBURG to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- PTW-FREIBURG
- Category
- Health
- Recall date
- February 28, 2024
- Units affected
- Not reported
- Sold at
- GA
- Recall number
- FDA-Z-1181-2024
- Made in
- Germany
- Issuing agency
- FDA
In context
- PTW-FREIBURG has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.