FDA Device recall Z-3174-2026
Brand Name: VERIQA
- FDA Device
- Class II
- ongoing
- Published 2026-09-23
On 2026-09-23 the FDA classified a Class II recall of Brand Name: VERIQA by Ptw Freiburg, citing 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 incor….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3174-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-04 |
| Published | 2026-09-23 |
| Last updated | 2026-09-29 05:30 UTC |
| Company | Ptw Freiburg |
| Distribution | US |
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.
Identifiers
| code_info | Model/Catalog Number: S070031.520; UDI-DI: +EPTWS070031Q5200; Software Version 3.1.18; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-29 05:30 UTC. Current status: ongoing.
Other recalls by Ptw Freiburg
- Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets…
FDA Device · Class II · 2024-02-28 · Ptw Freiburg - BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using ArrayCal (…
FDA Device · Class II · 2023-09-20 · Ptw Freiburg - PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05
FDA Device · Class II · 2015-09-02 · Ptw Freiburg
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3174-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.