FDA Medical devices recall ·
VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number:… recall
- Recall number
- Z-3174-2026
- Date
- (initiated August 4, 2026)
- Company / brand
- Ptw Freiburg
Lorracher Str. 7, Freiburg Im Breisgau, N/A, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18;
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3174-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.