The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2892-2026·Announced 2026-08-12

Philips Azurion interventional fluoroscopic X-ray systems recalled for potential hardware failures

Philips Azurion X-ray systems may lose imaging capability or motor functions due to unauthorized hard drives.

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: The recall involves a Class II device with no reported illnesses or injuries, but represents a risk-of-harm scenario where potential functional loss could occur due to unauthorized hardware modifications.

Plain-English summary

The U.S. Food and Drug Administration is recalling Philips Azurion interventional fluoroscopic X-ray systems because they may experience potential loss of imaging functionality, loss of motorized movement, or loss of data caused by unauthorized hard disk drives. These devices are distributed nationwide and affect all users of the specified model numbers across multiple series. Consumers are advised to contact their healthcare provider or the manufacturer immediately to arrange for replacement or repair of the affected systems. Until the issue is resolved, these systems should not be used for critical medical procedures requiring reliable imaging and motorized operation.

The recalled product

Product
Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbers: 722063, 722221. 2. Azurion 3 M15; Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12; Model Number: 722227. 4. Azurion 5 M20; Model Numbers…
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Interventional Fluoroscopic X-Ray System
Hazard
Affected units
3,341

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 Numbers (UDI Numbers): 722063 ((01)00884838085275(21)56
  • (01)00884838085275(21)96
  • (01)00884838085275(21)98
  • (01)00884838085275(21)80
  • (01)00884838085275(21)146
  • (01)00884838085275(21)3
  • (01)00884838085275(21)22
  • (01)00884838085275(21)153
  • (01)00884838085275(21)40
  • (01)00884838085275(21)70
  • (01)00884838085275(21)30
  • (01)00884838085275(21)19
  • (01)00884838085275(21)121
  • (01)00884838085275(21)18
  • (01)00884838085275(21)16
  • (01)00884838085275(21)14
  • (01)00884838085275(21)17
  • (01)00884838085275(21)53
  • (01)00884838085275(21)101
  • (01)00884838085275(21)143

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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