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Monarch Platform Recall Due to Auris Health, Inc. has identified through inte...

# Major Recall Alert: Monarch Platform Recalled Due to Software Malfunction Risk During Procedure Setup

Auris Health, Inc. has issued a major recall for its **Monarch Platform** due to a significant issue identified during internal testing. In rare cases, a restart of the system’s software application may lead to unintended robotic arm movement, posing potential safety risks during procedures. This malfunction highlights the importance of ensuring users are informed about the potential risks associated with the device. Read on for all the details of this recall, why it’s critical, and steps you should take to stay informed and protect your patients.

## Why This Recall is Important

The Monarch Platform, a robotic bronchoscopy system, is widely used in medical settings to assist with minimally invasive procedures. However, Auris Health, Inc. has found that, under rare conditions, a system software restart during procedure setup may cause the system to realign inaccurately.

This issue occurs if the software reinitializes the patient-side state to the **patient-left position** during a restart, even if the **patient-right position** was previously selected. This misalignment could lead to unintended robotic movement in the wrong direction, creating the risk of errors during subsequent steps in a medical procedure. Although rare, such malfunctions are concerning, as they may compromise patient safety if not detected immediately.

## Details of the Recall

Here’s a breakdown of the key details surrounding the Monarch Platform recall:

- **Category**: Bronchoscopy robotic platform system
- **Manufacturer**: Auris Health, Inc.
- **Product Name**: Monarch Platform
- **Issue**: Potential for software restart during setup, causing unintended misalignment of the robotic arm and mismatch between system state and user intention.
- **Why It’s Dangerous**: Unrecognized mismatches between system alignment and the intended patient position could lead to **robotic arm movement towards the wrong patient side**, posing potential procedural risks.
- **Date Announced**: October 2023

Auris Health, Inc. is working with regulatory agencies and healthcare providers to address this issue by notifying users and providing safety guidelines to prevent risks.

For further updates, you can access the official recall notice on the [Government of Canada Recall website](https://recalls-rappels.canada.ca/en/alert-recall/monarch-platform).

## What You Should Do

If you are a healthcare provider or institution currently using a Monarch Platform, take these steps immediately to minimize potential risks:

- **Check for Notifications**: Review all official recall notices from Auris Health, Inc. and regulatory agencies.
- **Update Operating Procedures**: Follow any interim guidelines or updates provided to avoid misalignment issues during the procedure setup.
- **Inspect Equipment Regularly**: Conduct regular inspection and setup testing of the Monarch Platform to ensure proper operational configurations.
- **Contact the Manufacturer**: Reach out to Auris Health, Inc. for any questions or additional guidance regarding the recall.

Should you encounter signs of unintentional system behavior, report the issue immediately to both the manufacturer and appropriate health authorities in your region.

## Stay Safe – Get Instant Recall Alerts

Keeping patients safe means staying informed. Don’t let recalls like this catch you off guard. Download our **Recall App** to access up-to-date product recall information, safety tips, and alerts directly from trusted sources, including government healthcare agencies.

Stay proactive and help your team deliver top-tier care by ensuring medical equipment is operating properly. Get the recall updates you need—when you need them—by downloading our app today!

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For more details about this recall and the specific risks associated with the Monarch Platform, visit the official recall page [here](https://recalls-rappels.canada.ca/en/alert-recall/monarch-platform). Take action today to ensure safe and effective use of your medical devices!

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