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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 FirmAugust 04, 2026
Date PostedSeptember 15, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3174-2026
Recall Event ID 99720
510(K)NumberK213370 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductBrand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18;
Code Information Model/Catalog Number: S070031.520; UDI-DI: +EPTWS070031Q5200; Software Version 3.1.18;
FEI Number 3007360740
Recalling Firm/
Manufacturer		 PTW FREIBURG
Lorracher Str. 7
Freiburg Im Breisgau Germany
Manufacturer Reason
for Recall		When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly, which may lead users to incorrectly omit the bolus during treatment and deliver the prescribed dose to the wrong tissue depth.
FDA Determined
Cause 2		Software design
ActionOn August 13, 2026 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: If a user is unsure whether a bolus must be used for treatment or not, VERIQA RT MonteCarlo 3D must not be used as the source of information. The user must rely exclusively on the information from the TPS and from the patient record to determine whether a bolus is used for treatment or not. VERIQA RT MonteCarlo 3D must not have any influence on the treatment workflow or on the treatment plan. This error will be fixed in the next VERIQA RT MonteCarlo 3D release. Please forward this notice to everyone in your organization, or in any other organization using VERIQA RT MonteCarlo 3D version 3.1.18, who needs to be aware of it.
Quantity in Commerce2
DistributionWorldwide - US Nationwide distribution in the states of GA, NY and the countries of Austria, Belgium, Switzerland, Czechia, Germany, Spain, France, Netherlands, Norway, Poland, Portugal, Romania, T¿rkiye, Chile, United Arab Emirates, Saudi Arabia, Mexico, Hong Kong, Brazil, Tajikistan, Ecuador, Iran, Thailand, Serbia, South Africa, Kazakhstan, Algeria.
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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