PTW FREIBURG recalls Brand Name: VERIQA

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.

Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18;

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.

• FDA enforcement recordOfficial FDA database entry for Z-3174-2026
• FDA 510(k) clearance · K213370The device's official FDA premarket clearance record
• FDA device classification · IYEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.5050The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find PTW FREIBURGSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.