VERIQA RT MonteCarlo 3D v3 Software
The software accounts for a bolus in a treatment plan but does not display it clearly.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
PTW Freiburg, based in Freiburg Im Breisgau, Germany, began a recall of its VERIQA RT MonteCarlo 3D v3 software, model S070031.520, version 3.1.18, on August 4, 2026, because 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.
The FDA added the recall to its Enforcement Report on September 15, 2026, with distribution worldwide, including the U.S. states of Georgia and New York.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its model number matches.
RT MonteCarlo 3D v3
- Model
- S070031.520
Details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Georgia, New York 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.
- Event ID
- 99720
- Recall No.
- Z-3174-2026
- Company
- PTW FREIBURGFreiburg Im Breisgau, Germany
- Hazard
- Software defect
- Recall type
- Voluntary: Firm initiated
- Customers told by
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
