PTW Freiburg recall: RT MonteCarlo 3D v3
PTW Freiburg is recalling RT MonteCarlo 3D v3 – 2. The U.S. Food and Drug Administration published the recall on September 23, 2026; it began on August 4, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | RT MonteCarlo 3D v3 |
| Brand | PTW Freiburg |
| Type | Medical devices |
| Classification | Class II |
| Recall date | August 4, 2026 |
| Published by FDA | September 23, 2026 |
| Quantity | 2 |
| Recall ID | 99720 |
Recalled products
- Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18;
- FDA recall number
- Z-3174-2026
- Codes, lots and dates
- Model/Catalog Number: S070031.520; UDI-DI: +EPTWS070031Q5200; Software Version 3.1.18;
- Quantity
- 2
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99720
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Freiburg Im Breisgau, N/A, Germany
Why it was recalled
The reason the FDA lists: “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.”
Where it was sold
Nationwide. Distribution as the FDA records it: “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 to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99720, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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About this recall
Is PTW Freiburg RT MonteCarlo 3D v3 recalled?
Yes. PTW Freiburg recalled it on August 4, 2026; FDA published it September 23, 2026 (Class II). Only the lots, dates or models listed on this page are included.
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 I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.