CanadaPhilips Azurion and Allura Xper systems (models including Azurion 7 B20/7 M12/7 M20/7 B12 and Allura Xper FD10/FD20/FD20 OR Table—catalog numbers listed in the notice) with X‑ray tube cooling units CU3101 manufactured between February 2016 and May 2020 are affected. The deaeration hose may degrade over time, potentially causing oil leakage that can reduce tube cooling, force the system into low‑dose fluoroscopy with the message “low load fluoroscopy flavor selected: tube cooler problem,” and in rare cases produce fumes that may trigger environmental detectors. Contact the manufacturer for additional information.
What's being recalled
Companies: Philips Medical Systems Nederland B.V., Veenpluis 6, Best, Netherlands, 5684 PC.
How to identify it
Affected products: Azurion 7 B20; Lot or serial number: Not applicable.; Model or catalogue number: 722 068
Affected products: Allura Xper FD10; Lot or serial number: Not applicable.; Model or catalogue number: ALLURA XPER FD10
Affected products: Allura Xper FD10; Lot or serial number: Not applicable.; Model or catalogue number: 001443
Affected products: Allura Xper FD20 (Product Of Allura Clarity Family); Lot or serial number: Not applicable.; Model or catalogue number: 722028
Affected products: Azurion 7 M12; Lot or serial number: Not applicable.; Model or catalogue number: 722 078
Affected products: Azurion 7 M20; Lot or serial number: Not applicable.; Model or catalogue number: 722 079
Affected products: Allura Xper FD10 (Product Of Alluraclarity Family); Lot or serial number: Not applicable.; Model or catalogue number: 722026
Affected products: Allura Xper FD20/10 (Product Of Alluraclarity Family); Lot or serial number: Not applicable.; Model or catalogue number: 722029
Affected products: Allura Xper FD20 OR Table (Product Of Alluraclarity Family); Lot or serial number: Not applicable.; Model or catalogue number: 722035
Affected products: Azurion 7 B12; Lot or serial number: Not applicable.; Model or catalogue number: 722 067
The hazard
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
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)