Reported Feb 28, 2024 · Ongoing

Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of…

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 · N/A

Is this the product you have?

  • Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.
Lot codes and dates
  • UDI-DI
    • EPTWS070031 Software VERIQA (S070031)
    • version 2.0 and 2.1
Amount recalled
1 US; 65 worldwide

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Ptw-Freiburg recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:09 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.