The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2258-2026·Announced 2026-06-03

Philips Azurion system hard drives may degrade and lose imaging

Philips Azurion interventional X-ray systems are being recalled because hard drives in the system PCs may lose performance as they age, potentially causing loss of imaging functionality.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 a hardware failure can cause loss of imaging during a procedure, a risk of harm with no injuries reported in the source.

Plain-English summary

Philips Azurion systems are being recalled across a range of model numbers, including Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20 and others listed in the recall notice. The action covers 3,069 units, 872 in the United States and 2,224 elsewhere.

It was identified that hard disk drives used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with a drive may, depending on the specific system PC in which the affected drive is installed, result in loss of imaging functionality. The FDA classified the action as Class II.

Distribution was worldwide, covering the United States nationwide and a large number of other countries. 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
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225), Azurion 7 B20 (722068, 722226), Azurion 7 M12 (722078, 722223), Azurion 7 M20…
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Interventional X-ray system
Hazard

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. Azurion 3 M12
  • Model: 722063
  • UDI: (01)00884838085275(21)122
  • (01)00884838085275(21)64
  • (01)00884838085275(21)56
  • (01)00884838085275(21)131
  • (01)00884838085275(21)84
  • (01)00884838085275(21)132
  • (01)00884838085275(21)98
  • (01)00884838085275(21)108
  • (01)00884838085275(21)77
  • (01)00884838085275(21)82
  • (01)00884838085275(21)47
  • (01)00884838085275(21)80
  • (01)00884838085275(21)146
  • (01)00884838085275(21)102
  • (01)00884838085275(21)117
  • (01)00884838085275(21)2
  • (01)00884838085275(21)149
  • (01)00884838085275(21)99

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 →

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