Philips Azurion 7B20/15 systems may show unusable dark fluoroscopy images

Plain-English summary

The Philips Azurion 7B20/15, model numbers 722068 and 722226, 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, is being recalled. The action covers 156 units, identified by the UDI codes in the recall notice.

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. According to the manufacturer, the dark image may result after the user performs a pedal tap, meaning shortly touching the footswitch pedal without generating an X-ray image, and 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 healthcare facilities rather than sold to consumers.

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

The recalled product

Product

Philips Azurion 7B20/15, Model Numbers: 722068, 722226 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

• software-anomaly
• dark-image
• imaging-failure
• class-ii

Affected units

156

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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