Recall Z-3174-2026— PTW FREIBURG

Name: FDA recall Z-3174-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-04

Class II · Ongoing

Class II FDA medical device recall by PTW FREIBURG, initiated 2026-08-04. It names one FDA 510(k) clearance: K213370. Product: Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18;. 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..

Recalling firm: PTW FREIBURG
Classification: Class II
Status: Ongoing
Initiated: 2026-08-04
Firm location: Freiburg Im Breisgau, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K213370 — VERIQAPtw-Freiburg Physikalisch-Technische-Werkstaetten·cleared 2022-03-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.