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

FDA device recall Z-1181-2024 · posted 2024-02-22 · Open, Classified

Recall details

Recalling firm

PTW-FREIBURG

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.

Action taken

PTW Dosimetry issued Urgent Medical Device Correction letter via email on 2/8/24. Letter states reason for recall, health risk and action to take: PTW recommends not using the Suppress gamma calculation function for ROIs where a high proportion of voxels are to be suppressed in the gamma calculation. Since the malfunction is limited to the GPR calculation of ROIs and does not affect the GPR calculation of the VERIQA Total volume, it is recommended to rely on the comparison based on VERIQA Total. PTW will correct the malfunction in the next software version. The corrected version will be made available to all VERIQA users. The above information should be taken into account by the customer until the installed VERIQA version has been updated. Pass this notice on to everyone at your facility/hospital or at another facility/hospital where the equipment is located who needs to know about it.

Root cause

Software design

Status

Open, Classified

Product code

IYE

Quantity affected

1 US; 65 worldwide

Distribution

GA

Date initiated

2024-02-08

Date posted

2024-02-22

Location

Freiburg Im Breisgau, Germany

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