Health product recall

Azurion and Allura Xper Systems

Last updated

Summary

Product
Azurion and Allura Xper Systems
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected 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.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

Philips Medical Systems Nederland B.V.

Veenpluis 6, Best, Netherlands, 5684 PC

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82040

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