Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18;
FDA Recall Z-3174-2026 · Posted 2026-09-15
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Recalling FirmPTW FREIBURG
Recall StatusOpen, Classified
Product CodeIYE
Date Initiated2026-08-04
Product Quantity2
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.
Firm Action
On 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.
Root Cause
Software design
Distribution Pattern
Worldwide - 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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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