PTW-FREIBURG: Medical Device Recall in 2024 - (Recall #: Z-1181-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 8, 2024

Date Posted: February 28, 2024

Recall Number: Z-1181-2024

Event ID: 93988

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 1 US; 65 worldwide

Code Information:

UDI-DI: EPTWS070031 Software VERIQA (S070031), version 2.0 and 2.1

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated