Class IIDeviceOngoing

PTW FREIBURG

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

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.

Details

Recall number: Z-3174-2026
Event ID: 99720
Recall initiated: Aug 4, 2026
Classified: Sep 15, 2026
Reported: Sep 23, 2026
Quantity: 2
Distribution: 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.
Initiated by: Voluntary: Firm initiated
Firm notification: E-Mail
Firm location: Freiburg Im Breisgau, N/A, Germany
Lot / code info: Model/Catalog Number: S070031.520; UDI-DI: +EPTWS070031Q5200; Software Version 3.1.18;