Official recall record
Azurion and Allura Xper Systems
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2026-05-06
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.