Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Software VERIQA (S070031) Recalled by PTW-FREIBURG Due to Software: If the user excludes voxels from the...

Date: February 8, 2024
Company: PTW-FREIBURG
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact PTW-FREIBURG directly.

Affected Products

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.

Quantity: 1 US; 65 worldwide

Why Was This 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.

Where Was This Sold?

This product was distributed to 1 state: GA

Affected (1 state)Not affected

About PTW-FREIBURG

PTW-FREIBURG has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report