# Major Recall Alert: Hamilton-C2 Intensive Care Ventilator Recalled Due to Malfunction in Neonatal Use
Hamilton Medical AG has issued a critical recall for its HAMILTON-C2 Intensive Care Ventilator due to a potential malfunction when used long-term with neonatal patients. If an affected ventilator is used continuously for 91 days without restarting the device, it may switch to "ambient state" mode, resulting in the immediate cessation of ventilation. This issue affects neonatal patients using HAMILTON-C2 ventilators with the neonatal option installed.
Read on to understand the risks, details about the recall, and essential steps to safeguard patient safety.
## Why This Recall is Important
The HAMILTON-C2 ventilator is designed to provide high-level respiratory support, often functioning as a life-saving device for vulnerable neonatal patients. The malfunction in question poses a significant risk because:
- The device switches to "ambient state" mode, stopping ventilation without prior warning.
- Although the ventilator alarms audibly and visually during this state, immediate intervention is necessary to restart care.
- Extended continuous use (91 days or more) without restarting the ventilator is the trigger for this issue, a scenario that could occur unnoticed in long-term care settings.
Since neonatal patients face heightened risks from ventilation disruptions, healthcare providers, caretakers, and hospitals need to address this concern urgently.
## Details of the Recall
Hamilton Medical AG first communicated this issue in May 2023 (Ref: CER 110972) and later expanded their advisory in January 2025 (Ref: FSCA-2025-01-01). Below are the key details of the current recall:
- **Affected Product**: HAMILTON-C2 Intensive Care Ventilator with neonatal option installed.
- **Issue**: If operated for 91 continuous days with neonatal patients without a device restart, the ventilator enters “ambient state,” stopping ventilation immediately.
- **Alarm Notifications**: During “ambient state,” visual and audible alarms alert users, requiring manual intervention to resume ventilation.
- **Safety Communications**: This recall represents an update to previous Field Safety Notices (FSNs).
- **Manufacturer’s Action**: Hamilton Medical AG has not reported any new complaints related to this issue since May 2023.
For complete recall details, refer to the official Health Canada notice: [Hamilton-C2 Intensive Care Ventilator Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/hamilton-c2-intensive-care-ventilator).
## What You Should Do
If you or your facility uses a HAMILTON-C2 ventilator for neonatal patients, follow these precautionary steps:
- **Restart the Device Regularly**: Be proactive and ensure the ventilator is restarted before reaching 91 continuous days of cumulative use.
- **Review Safety Instructions**: Check the manufacturer’s updated Field Safety Notice (FSN) to confirm proper device usage and maintenance protocols.
- **Contact the Manufacturer**: If you encounter issues or need further guidance, contact Hamilton Medical AG immediately.
- **Report Incidents**: If you experience a malfunction, report it to Health Canada or your local health authority.
Taking these steps will help mitigate risks and ensure optimal device performance for neonatal patients.
## Stay Safe – Get Instant Recall Alerts
With evolving medical device technology, staying informed about recalls and safety updates is crucial. Don’t miss vital alerts that could impact your healthcare decisions and patient safety.
**Stay proactive – Download our Recall Alert App today!** With instant notifications, detailed recall information, and safety tips, you’ll always be one step ahead.
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For the official recall details, visit the Health Canada advisory: [Hamilton-C2 Intensive Care Ventilator Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/hamilton-c2-intensive-care-ventilator).
Your vigilance could save lives – act immediately if you own or operate this device!