The Recall Desk
HighFDA (Devices)·Z-2502-2025·Announced 2025-09-10

Azurion imaging systems recalled because single phase UPS may fail on power loss

Philips Azurion systems configured with a 1 Phase UPS are recalled because they may shut down and/or fail to start up if power to the system is lost. 1,861 units are affected.

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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; an interventional imaging system that shuts down or fails to start could interrupt a procedure, and no injuries are reported.

Plain-English summary

Philips Azurion systems configured with a 1 Phase Uninterruptible Power Supply are being recalled across the Azurion family (R1.x, R2.x), including the Azurion 3 M12 (model 722063), Azurion 3 M15 (model 722064) and Azurion 7 B12, with serial numbers listed in the recall notice. The recall covers 1,861 units distributed nationwide in the United States and in many other countries.

Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply have the potential of shutting down and/or not starting up if power to the system is lost. The FDA classified the action as Class II.

Imaging sites operating these systems should follow the manufacturer's instructions for inspection and correction.

The recalled product

Product
Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Az
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Imaging System
Hazard
Affected units
1,861

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 (20)

  • 1. Model Number/System Code (UDI)
  • Serial Numbers: 722063 (00884838085275)
  • 25
  • 151
  • 91
  • 85
  • 90
  • 86
  • 107
  • 89
  • 88
  • 87
  • 120
  • 153
  • 96
  • 108. 2. Model Number/System Code (UDI)
  • Serial Numbers: 722064 (00884838085282)
  • 64
  • 260
  • 261

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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Same hazard · power supply

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