Products: endoluminal-robot. Risk band: Elevated RobotRisk index 27.0/100 (incidents/exposure, time-weighted) · 96th percentile of 162 medical robotics companies.
Noah Medical shows three FDA Class II recalls of the same Galaxy System platform, spanning March 2024 through September 2025, all severity 3 and all recall-type entries. The repetition of recalls against the same device family (Galaxy System, including a controller-specific recall) indicates a recurring rather than isolated issue with that product line. The index of 27.2 sits at the 96.3rd percentile within medical-robotics, an elevated band, meaning Noah Medical's recorded activity is higher than nearly all peers in that category. The record is entirely regulator-driven (FDA recall classifications), with a consistent severity level and no escalation to injury or fatality entries, and the pattern points to a persistent single-product quality issue rather than a broad safety event.
| Sev | Date | Type | Location | Incident | Source |
|---|---|---|---|---|---|
| S3 | 09/12 2025 |
recall | — | FDA Class II recall: Brand Name: Galaxy System · Brand Name: Galaxy System | openFDA enforcement |
| S3 | 10/28 2024 |
recall | — | FDA Class II recall: Galaxy System (GAL-001). · Galaxy System (GAL-001). | openFDA enforcement |
| S3 | 03/09 2024 |
recall | — | FDA Class II recall: Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) · Galaxy System REF GAL-001 (specificall… | openFDA enforcement |