Official recall record

Philips Azurion 3 M12. Model Numbers: 722063, 722221.

US FDA — Medical Devices · 2026-10-06 · NetherlandsClass II

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2026-10-06
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

Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.

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 2026-11-13.

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

2026-10-06 · US FDA — Medical Devices
Philips Azurion 5 M20. Model Numbers: 722228, 722281.
2026-10-06 · US FDA — Medical Devices
Philips Azurion S. Model Number: 722285.
2026-10-06 · US FDA — Medical Devices
Philips Azurion 7 M20. Model Numbers: 722079, 722224, 722282.

All 90 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.