# Major Recall Alert: Edan Central Monitoring System, Patient Monitors, and Fetal & Maternal Monitors Recalled Due to Misleading IP Address Labeling and Configuration Issue
Health Canada has issued a **major recall** affecting several Edan monitoring devices, including **Central Monitoring System**, **F6 and F9 Fetal & Maternal Monitors**, **Patient Monitors**, and **Vital Signs Monitors**. The recall was announced on **October 31, 2023**, highlighting critical concerns about **misleading labeling issues** and a **default IP configuration** in the Instructions for Use (IFU).
The issue arises from the use of an **inappropriate publicly routable IP address** within the IFU and default system settings, potentially leading to confusion or security vulnerabilities. Let’s dive deeper into why this recall matters and what users should do to ensure safety and compliance.
## Why This Recall is Important
This recall is particularly significant because the affected devices are designed for use in medical environments, monitoring patient health and vital signs—potentially lifesaving functions. Here’s why users of these devices need to act immediately:
- The issue involves an **incorrect demonstration IP address** within the user manual.
- The **default factory setting** also used a publicly routable IP address. While this setting is not hard-coded and can be modified by users, it poses potential security risks if left unchanged in critical clinical applications.
- Correct network configuration is essential to safeguard sensitive patient data and prevent potential breaches in connected medical systems.
Medical devices connected to external networks must utilize appropriate IP configurations to meet safety and privacy standards. Misconfigured devices in hospital systems can have far-reaching implications, making this recall crucial to mitigate risks.
## Details of the Recall
**Category:** Labeling issue and factory default configuration issue.
- **Labeling Issue:** The device’s Instructions for Use (IFU) contained an **inappropriate publicly routable IP address** for demonstrating user-configurable IP settings.
- **Default Setting Issue:** Factory configurations mistakenly utilized the same inappropriate IP address as a default default, although users can modify this setting.
### Affected Devices:
The recall affects a wide range of devices, including:
- **Central Monitoring System**
- **Central Monitoring System (For Patient Monitors)**
- **F6 Fetal & Maternal Monitor**
- **F9 Fetal & Maternal Monitor**
- **Patient Monitor**
- **Vital Signs Monitor**
- **Vital Signs Monitor (Non-Continuous)**
### Date Announced:
The recall was officially announced on **October 31, 2023**.
For full details, visit the official Health Canada recall listing at [recalls-rappels.canada.ca](https://recalls-rappels.canada.ca/en/alert-recall/edan-patient-monitors).
## What You Should Do
If you or your healthcare facility uses any of the affected devices, follow these steps immediately:
1. **Review the Device Configuration:** Verify the current IP address settings on your device and ensure they are configured to a safe and appropriate address.
2. **Update the Instructions for Use (IFU):** Replace the recalled IFU or update it based on the guidance provided by the manufacturer.
3. **Contact the Manufacturer:** Reach out to Edan Instruments’ customer support for further instructions, including updated user guidance.
4. **Maintain Best Practices for Network Security:** Always configure medical devices to adhere to your organization’s cybersecurity standards, especially for network-connected equipment.
Failure to address these labeling and IP configuration issues could lead to potential operational disruptions or vulnerabilities in sensitive healthcare environments.
## Stay Safe – Get Instant Recall Alerts
Health Canada’s recall of Edan patient monitors and related devices underscores the importance of keeping medical equipment safe and up-to-date. To stay on top of the latest recalls and ensure the safety of your medical devices:
👉 **Download our Recall Alerts App** – Get instant notifications about critical recalls that could impact your home, workplace, or healthcare facility. Stay informed and take action quickly to safeguard your devices and systems.
Don’t let this recall catch you off guard—act now to ensure your equipment operates securely and complies with the latest standards. For more information, visit [Health Canada Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/edan-patient-monitors).
Remember: Safety starts with being informed!