United StatesThe VERIQA RT MonteCarlo 3D v3 software (Brand: VERIQA; Model/Catalog S070031.520; UDI‑DI +EPTWS070031Q5200; Software Version 3.1.18) is being recalled by PTW Freiburg. 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's being recalled
Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18;
Recalling firm: PTW Freiburg, Freiburg Im Breisgau, N/A, Germany.
How to identify it
Model/Catalog Number: S070031.520; UDI-DI: +EPTWS070031Q5200; Software Version 3.1.18;
The hazard
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 to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)