The Recall Desk
HighFDA (Devices)·Z-2286-2026·Announced 2026-06-10

Philips Azurion 5M12 systems may show unusable dark fluoroscopy images

Philips Azurion 5M12 systems with the Roadmap Pro software key are being recalled because a pedal tap may produce a dark image that is not clinically usable.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall where imaging used to guide a procedure may become unusable, a risk of harm with no injuries reported in the source.

Plain-English summary

The Philips Azurion 5M12, model number 722227, 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 three 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 number, software release and UDI codes above and follow the instructions issued by Philips.

The recalled product

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
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Interventional X-ray system
Hazard
Affected units
3

Is your product affected?

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

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Related recalls

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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Same hazard · software anomaly

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