Official recall record
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2026-04-28
- Country of alert
- Netherlands
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00884838085275
- Brand on record
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-06-09.
Same barcode in other registries
The same EAN appears in 6 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2023-03-21 · US FDA — Medical Devices
Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) A - 2025-01-13 · US FDA — Medical Devices
Azurion 3 M12 System Code: (1) 722063 (2) 722221 - 2023-12-12 · US FDA — Medical Devices
Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -7 - 2024-07-15 · US FDA — Medical Devices
Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for I - 2026-03-03 · US FDA — Medical Devices
Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;
Other recalls from this brand
- 2026-07-16 · US FDA — Medical Devices
Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223 - 2026-07-16 · US FDA — Medical Devices
Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Soft