HexaPOD
Model P10603-300 · 3C-Medical Intelligence GmbH · DI 04056719002244
JAI — Couch, Radiation Therapy, Powered · Class II · 21 CFR 892.5770
UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (2)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2018-05-16 | Z-2535-2018 | Class II | Terminated | Upon completion of a 6D workflow, the HexaPOD evo Module may be in a tilted state if it is moved to the position used for 3D (non-iGUIDE) treatments resulting in incorrect patient positioning. | k number procode |
| 2014-04-17 | Z-1514-2014 | Class II | Terminated | If screws are not properly tightened with a torque wrench they may become loose over time. | k number procode |
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2024-02 | 0 | 2 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K072898 — cited as predicate by K143485
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — 3C-Medical Intelligence GmbH
- NAI 2025-06-05 3C Medical Intelligence GmbH · 0 citations
- NAI 2025-06-05 3C Medical Intelligence GmbH · 0 citations
- NAI 2015-11-12 3C Medical Intelligence GmbH · 0 citations
- NAI 2015-11-12 3C Medical Intelligence GmbH · 0 citations