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U.S. Department of Health and Human Services

Class 2 Device Recall VERIQA

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 Class 2 Device Recall VERIQAsee related information
Date Initiated by FirmFebruary 08, 2024
Date PostedFebruary 22, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1181-2024
Recall Event ID 93988
510(K)NumberK213370 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductSoftware 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.
Code Information UDI-DI: EPTWS070031 Software VERIQA (S070031), version 2.0 and 2.1
Recalling Firm/
Manufacturer		 PTW-FREIBURG
Lorracher Str. 7
Freiburg Im Breisgau Germany
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionPTW 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.
Quantity in Commerce1 US; 65 worldwide
DistributionGA
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = IYE
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