# Monarch Platform > Active: United States. Medical device record on deviCERTS, compiled from public registries. - Canonical page: - Manufacturer: [Auris Health, Inc.](https://devicerts.com/manufacturers/auris-health-inc) (United States) - Device class: Class II (US FDA) - FDA product code: EOQ ## Registrations and authorizations - **510(k)** · FDA 510(k) · United States · K211493 · decision 2021-07-09 · decision SESE · status: Active ## Recalls - Z-1383-2026 · Class II · ongoing · initiated 2026-01-21: Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to patient-left position; and if right position was previously selected, this may lead to unanticipated robotic arm positioning toward patient-left, may result in contact with patient/endotracheal tube. - Z-0051-2025 · Class II · ongoing · initiated 2024-08-02: Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock. ## Identifiers - 510(k) Number: K211493 [FDA 510(k)] - FDA product code: EOQ [FDA 510(k)] ## Classification - Device class: Class II [FDA 510(k)] - Regulation: 21 CFR Part 874.4680 [FDA 510(k)] - Advisory committee: Ear, Nose, Throat [FDA 510(k)] - FDA decision: SESE [FDA 510(k)] ## Source and citation - Cite as: Monarch Platform, Auris Health, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/monarch-platform-eoq (data as of 2026-11-15). - Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA recalls](https://open.fda.gov/apis/device/recall/) - Registry records last synced: 2026-11-08 - Statuses computed as of: 2026-11-15 - JSON: - Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms. - Attribution: DevicErts, https://devicerts.com/devices/monarch-platform-eoq - Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.