Recall Z-1181-2024— PTW-FREIBURG

Name: FDA recall Z-1181-2024
Creator: U.S. Food and Drug Administration
Published: 2024-02-08

Class II · Ongoing

Class II FDA medical device recall by PTW-FREIBURG, initiated 2024-02-08. It names one FDA 510(k) clearance: K213370. Product: 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.. Reason: 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..

Recalling firm: PTW-FREIBURG
Classification: Class II
Status: Ongoing
Initiated: 2024-02-08
Firm location: Freiburg Im Breisgau, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K213370 — VERIQAPtw-Freiburg Physikalisch-Technische-Werkstaetten·cleared 2022-03-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.