Azurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
The deaeration hose in Philips Azurion X-ray tube cooling units may degrade over time and leak oil, affecting cooling performance and automatically triggering low-dose fluoroscopy mode.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall affecting a critical cooling component of X-ray systems. Although no adverse health events are reported in the source, the hazard poses a risk of harm because degraded cooling performance and oil leakage could compromise system function and patient safety during diagnostic procedures.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling Azurion X-ray systems due to a defect in the deaeration hose found in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020. The hose may degrade over time, potentially resulting in oil leakage.
When oil leaks from the deaeration hose, the cooling performance of the X-ray tube is affected. If the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy mode and displays the message "Low load fluoroscopy flavor selected: Tube cooler problem." This condition cannot be resolved by restarting the system.
The recall affects 1,651 units worldwide: 592 in the United States and 1,359 internationally across numerous countries including Canada, Australia, France, Germany, Japan, and the United Kingdom. Affected facility operators should contact Philips for guidance on inspection and potential repair or replacement of the deaeration hose.
The recalled product
- Product
- Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079, 722224).
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- oil-leakage
- cooling-system-failure
- equipment-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1. Azurion 3 M12
- Model: 722063
- UDI: (01)00884838085275(21)64
- (01)00884838085275(21)56
- (01)00884838085275(21)77
- (01)00884838085275(21)82
- (01)00884838085275(21)47
- (01)00884838085275(21)80
- (01)00884838085275(21)102
- (01)00884838085275(21)117
- (01)00884838085275(21)2
- (01)00884838085275(21)99
- (01)00884838085275(21)44
- (01)00884838085275(21)3
- (01)00884838085275(21)62
- (01)00884838085275(21)61
- (01)00884838085275(21)22
- (01)00884838085275(21)29
- (01)00884838085275(21)40
- (01)00884838085275(21)70
Distribution
Distributed nationwide across the United States.