Public recall detail

Azurion and Allura Xper Systems

2026-05-06

medium
Radiology Performance
Quick summary

Quick summary: Azurion and Allura Xper Systems. Reason: Performance. Category: Radiology. Date: 2026-05-06.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Azurion and Allura Xper Systems. Reason: Performance. Category: Radiology. Date: 2026-05-06.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
ProductAzurion and Allura Xper Systems
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82040

Affected products

ProductAzurion 7 B20
LotNot applicable.
Model722 068
Serial numberNot applicable.
DescriptionAzurion 7 B20
ProductAllura Xper FD10
LotNot applicable.
ModelALLURA XPER FD10
Serial numberNot applicable.
DescriptionAllura Xper FD10
ProductAllura Xper FD10
LotNot applicable.
Model001443
Serial numberNot applicable.
DescriptionAllura Xper FD10
ProductAllura Xper FD20 (Product Of Allura Clarity Family)
LotNot applicable.
Model722028
Serial numberNot applicable.
DescriptionAllura Xper FD20 (Product Of Allura Clarity Family)
ProductAzurion 7 M12
LotNot applicable.
Model722 078
Serial numberNot applicable.
DescriptionAzurion 7 M12
ProductAzurion 7 M20
LotNot applicable.
Model722 079
Serial numberNot applicable.
DescriptionAzurion 7 M20
ProductAllura Xper FD10 (Product Of Alluraclarity Family)
LotNot applicable.
Model722026
Serial numberNot applicable.
DescriptionAllura Xper FD10 (Product Of Alluraclarity Family)
ProductAllura Xper FD20/10 (Product Of Alluraclarity Family)
LotNot applicable.
Model722029
Serial numberNot applicable.
DescriptionAllura Xper FD20/10 (Product Of Alluraclarity Family)
ProductAllura Xper FD20 OR Table (Product Of Alluraclarity Family)
LotNot applicable.
Model722035
Serial numberNot applicable.
DescriptionAllura Xper FD20 OR Table (Product Of Alluraclarity Family)
ProductAzurion 7 B12
LotNot applicable.
Model722 067
Serial numberNot applicable.
DescriptionAzurion 7 B12

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Radiology
CompaniesPhilips Medical Systems Nederland B.V. Veenpluis 6, Best, Netherlands, 5684 PC
Recall date2026-04-29
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82040
Background{}
CompaniesPhilips Medical Systems Nederland B.V. Veenpluis 6, Best, Netherlands, 5684 PC
AudiencesHealthcare
Source updated2026-05-06

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

Official source Monitor products Back to recalls

Starting...

Related recalls

Similar recalls and safety notices.

Loading related recalls...