# Major Recall Alert: Deaeration Hose Issue in Allura Xper and Azurion X-ray Systems
The Government of Canada has issued a significant recall impacting several Allura Xper and Azurion systems manufactured between February 2016 and May 2020. The recall concerns a critical safety issue involving the deaeration hose in CU3101 X-ray tube cooling units, which may degrade over time, potentially leading to hazardous oil leakage. This situation could compromise the performance of medical imaging equipment, posing risks to both healthcare providers and patients.
## Why This Recall is Important
This recall addresses serious concerns regarding the safety and functionality of widely used X-ray systems in medical facilities. Here’s why it matters:
- **Potential Oil Leakage**: Degradation of the deaeration hose can result in oil leakage within the cooling units, affecting the cooling performance of X-ray tubes.
- **Impact on System Performance**: If oil flow drops below the required threshold, the system automatically transitions to low-dose fluoroscopy mode, displaying the message, “low load fluoroscopy flavor selected: tube cooler problem.” This issue cannot be resolved by restarting the machine.
- **Oil Containment Concerns**: In most cases, leaked oil remains within the system, but in rare instances of significant leakage, it may escape the containment area, potentially contacting hot surfaces.
- **Risk of Fumes and Detection System Activation**: Oil fumes generated from contact with hot surfaces can activate environmental detection systems, potentially disrupting procedures and creating safety hazards in clinical environments.
These risks demand immediate attention to ensure the safety of patients, medical personnel, and equipment functionality.
## Details of the Recall
This recall affects the following products within the Allura Xper and Azurion system families:
### Impacted Products and Models:
- **Allura Xper**:
- FD10
- FD10 (Product of Allura Clarity Family)
- FD20 (Product of Allura Clarity Family)
- FD20 OR Table (Product of Allura Clarity Family)
- FD20/10 (Product of Allura Clarity Family)
- **Azurion**:
- Azurion 7 B12
- Azurion 7 B20
- Azurion 7 M12
- Azurion 7 M20
### Manufacturing Period:
- February 2016 to May 2020
### Root Cause:
- Degradation of the deaeration hose within CU3101 X-ray tube cooling units over time.
For further official details, please visit the [Government of Canada Recall Page](https://recalls-rappels.canada.ca/en/alert-recall/azurion-and-allura-xper-systems).
## What You Should Do
If your facility utilizes any of the products listed above, follow these steps to ensure safety:
1. **Immediate Inspection**: Healthcare facilities should inspect all affected systems for any signs of oil leakage or functional inconsistencies.
2. **Contact Supplier**: Reach out to your Philips supplier or another designated distributor for confirmation on next steps, repair guidance, or replacement parts.
3. **Adhere to Recall Instructions**: Follow all procedures outlined by Philips or your local regulatory body regarding decommissioning or resolving the impacted units.
Be proactive and ensure your facility’s equipment complies with safety standards to avoid any unexpected interruptions in care.
## Stay Safe – Get Instant Recall Alerts
Recalls like this highlight the critical need for staying up to date on medical device safety issues. Never miss an important update.
Download our **Recall Alert App** today for instant notifications about product recalls relevant to your sector, ensuring the safety of your team, patients, and equipment.
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For more information and updates on this recall, visit the [Government of Canada’s Official Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/azurion-and-allura-xper-systems).
By staying informed and taking immediate action, healthcare facilities can mitigate risks and maintain the highest standards of safety and patient care.