FDA-Device2026-09-23Class IIPROCESSING DEFECT

PTW Freiburg VERIQA RT MonteCarlo 3D v3 software recalled for unclear bolus display in dose calculations

OTHERNationwide distributionMedical devices Baby & kids

What this means

The VERIQA RT MonteCarlo 3D v3 radiation therapy planning software includes bolus (a material placed on the skin to modify radiation dose) in dose calculations, but does not clearly display that the bolus is accounted for. This may cause treatment staff to accidentally skip the bolus during treatment, leading to radiation being delivered to the wrong tissue depth.

If you use this software version (3.1.18, Model S070031.520), verify that any bolus is visually confirmed before each treatment.
Contact PTW Freiburg or your radiation oncology supervisor for guidance on secondary dose calculations involving bolus.
Check with the manufacturer for a software update or corrective instructions.

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The agency's original wording

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

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.

Affected count

Manufactured in

Lorracher Str. 7, N/A, Freiburg Im Breisgau, N/A, Germany

Products

Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3174-2026

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