Recall Z-3174-2026 · IYE Accelerator, Linear, Medical
PTW FREIBURG
Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18;
| Date | Sep 15, 2026 (initiated Aug 4, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | On August 13, 2026 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: If a user is unsure whether a bolus must be used for treatment or not, VERIQA RT MonteCarlo 3D must not be used as the source of information. The user must rely exclusively on the information from the TPS and from the patient record to determine whether a bolus is used for treatment or not. VERIQA RT MonteCarlo 3D must not have any influence on the treatment workflow or on the treatment plan. This error will be fixed in the next VERIQA RT MonteCarlo 3D release. Please forward this notice t |
| Quantity | 2 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213370 | VERIQA Ptw-Freiburg Physikalisch-Technische-Werkstaetten, Mar 30, 2022 |