PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: 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

Company / brand

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Product

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 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

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Product quantity

167 units

City

Best

Country

Netherlands

Event id

98977

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