Philips Azurion 7M12 Roadmap Pro may produce unusable dark images

Plain-English summary

Philips Azurion 7M12 systems, model numbers 722078 and 722223, with software releases R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 and the Roadmap Pro software key, are being recalled. The action covers 167 units.

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, briefly touching the footswitch pedal without generating an X-ray image; the pedal tap may cause a dark image with the next fluoroscopy run. The FDA classified the action as Class II.

Distribution was nationwide in the United States. The systems are installed in hospital interventional suites rather than sold to consumers.

Facilities should identify affected systems using the model numbers and UDI codes in the recall notice and follow the instructions issued by Philips.

The recalled product

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

Manufacturer

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Category

Medical Device — Interventional X-ray system

Hazard

• imaging-loss
• software-issue
• roadmap-pro
• class-ii

Affected units

167

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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