⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: 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 k

Medical DevicesSource: FDA (device) · Date: 2026-06-10

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Product
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
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution.
Recall initiated
2023-12-07
Code info
UDI (01)00884838099227(21)88, (01)00884838099227(21)135, (01)00884838099227(21)63.
Product quantity
3 units
City
Best
Country
Netherlands
Event id
98977
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