Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (

FDA device recall Z-2227-2026 · posted 2026-05-21 · Open, Classified

Recall details

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Reason for recall

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.

Action taken

On April 28, 2026 URGENT Medical Device Correction letters were sent to customers. Actions to be taken: 1. Circulate this URGENT Medical Device Correction letter to all users of the system so that they are aware of the issue. 2. In case the affected system has been transferred to another organization, please send a copy of this URGENT Medical Device Correction letter to that organization and inform Philips about this transfer through your local Philips representative. 3. Keep this letter with the documentation of the system until Philips corrects your system. Ensure that the letter is in a place likely to be seen/viewed. 4. If you experience the issue described in this letter, please report it to your local Philips representative. Actions planned by Philips IGT Systems to correct the issue Starting in Q1 2027, Philips will replace the deaeration hose in the CU3101 tube cooling unit in all affected systems. Your local Philips representative will contact you to schedule a visit to replace the deaeration hose once available.

Root cause

Component design/selection

Status

Open, Classified

Product code

OWB

Quantity affected

1651 units (592 US, 1359 OUS)

Distribution

Domestic: Nationwide; International: Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Chile,

Date initiated

2026-04-28

Date posted

2026-05-21

Location

Best, Netherlands