Device recall
Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18;
- Recall number
- Z-3174-2026
- Event id
- 99720
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- PTW FREIBURG
- Report date
- Sep 23, 2026
- Posted
- Sep 15, 2026
- Initiated
- Aug 4, 2026
- Center classification date
- Sep 15, 2026
- Product code
- IYE
- Device type
- Accelerator, Linear, Medical
- Reason
- 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.
- Root cause
- Software design
- Quantity
- 2
- Code info
- Model/Catalog Number: S070031.520; UDI-DI: +EPTWS070031Q5200; Software Version 3.1.18;
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K213370
- Location
- Freiburg Im Breisgau, N/A, Germany