Official recall record

Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro So

US FDA — Medical Devices · 2023-12-07 · NetherlandsClass II

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2023-12-07
Country of alert: Netherlands
Alert level: Class II
Alert type: recall
Barcode (EAN/GTIN): 00884838099241
Brand on record: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

What the authority reported

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

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 2026-09-16.

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

Same barcode in other registries

The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

2024-02-06 · US FDA — Medical Devices
Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surg

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 3 M12. Model Numbers: 722063, 722221.

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.