# Monarch™ Software Tower v2.2.5 Version 2.2.5

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/monarch-software-tower-v2-2-5-version-2-2-5>
- Manufacturer: [Auris Health, Inc.](https://devicerts.com/manufacturers/auris-health-inc) (United States)
- Device class: Class II (US FDA)
- FDA product code: EOQ, JAK
- GMDN: Robotic surgical system application software (43265)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 10810068810766 · listed 2024-02-16 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K211493 · decision 2021-07-09 · decision SESE · status: Active · from GUDID

## 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.

## Identity

- Trade name: Monarch™ Software Tower v2.2.5 [FDA GUDID (AccessGUDID)]
- Generic name: Robotic surgical system application software [FDA GUDID (AccessGUDID)]
- Model / reference: Version 2.2.5 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 10810068810766 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K211493 [FDA GUDID (AccessGUDID)]
- FDA product code: EOQ [FDA GUDID (AccessGUDID)]; JAK [FDA GUDID (AccessGUDID)]
- GMDN term: Robotic surgical system application software (43265) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 874.4680 [FDA GUDID (AccessGUDID)]; 892.1750 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Monarch™ Software Tower v2.2.5 Version 2.2.5, Auris Health, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/monarch-software-tower-v2-2-5-version-2-2-5 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/monarch-software-tower-v2-2-5-version-2-2-5.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-software-tower-v2-2-5-version-2-2-5
- 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.