Recall MonitorAzurion and Allura Xper Systems
· Published by Health Canada · Official notice
Details
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Azurion 7 B20 | Not applicable. | 722 068 |
| Allura Xper FD10 | Not applicable. | ALLURA XPER FD10 |
| Allura Xper FD10 | Not applicable. | 001443 |
| Allura Xper FD20 (Product Of Allura Clarity Family) | Not applicable. | 722028 |
| Azurion 7 M12 | Not applicable. | 722 078 |
| Azurion 7 M20 | Not applicable. | 722 079 |
| Allura Xper FD10 (Product Of Alluraclarity Family) | Not applicable. | 722026 |
| Allura Xper FD20/10 (Product Of Alluraclarity Family) | Not applicable. | 722029 |
| Allura Xper FD20 OR Table (Product Of Alluraclarity Family) | Not applicable. | 722035 |
| Azurion 7 B12 | Not applicable. | 722 067 |
Issue
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the x-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message "low load fluoroscopy flavor selected: tube cooler problem". This condition cannot be resolved by restarting the system. Under normal conditions, any leaked oil is contained within the system. In rare cases of more significant leakage, oil may extend beyond the intended containment area. If oil then comes into contact with hot surfaces, fumes may be generated. these fumes may activate environmental detection systems.