Official recall record

Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1

US FDA — Medical Devices · 2025-12-12 · NetherlandsClass II

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2025-12-12
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

Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error.

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.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · Netherlands · all filters

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

All 73 official recall notices naming PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. on this site →

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.