Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

Check your package for

UDI (01)00884838099227(21)88, (01)00884838099227(21)135, (01)00884838099227(21)63.

Why: 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.
Distributed: US Nationwide distribution.
Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Announced: 10 June 2026
Recall began: 7 December 2023

Every recall — food, medication, or medical device — is shown word-for-word from the official FDA or USDA notice, with a link straight to it. Nothing here is summarised, reworded, or filled in. This site is not affiliated with any government agency.