The Recall Desk
HighFDA (Devices)·Z-1113-2026·Announced 2026-01-28

Azurion imaging systems recalled over two software issues affecting imaging

Philips is recalling 228 Azurion systems on software version R3.1 over two software issues that may result in loss of imaging, loss of motorized movement, incorrect image content or loss of data.

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: Scored 3 under the risk-of-harm criterion: the firm states the faults may produce incorrect image content as well as loss of imaging and motorized movement, and no injuries are reported.

Plain-English summary

The Philips Azurion system running software version R3.1 is being recalled by Philips Medical Systems Nederland B.V. Affected model numbers and system product names, including Azurion 3 M12, are recorded in the enforcement record.

Philips has identified two software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data. The record describes Issue 1 as the system remaining in continuous restart mode after start-up, and Issue 2 as a longitudinal position error, applicable only to systems with a Poly-G3 frontal stand.

The record lists 228 units and states that all are outside the United States. Distribution was international, covering the countries listed in the enforcement record. The FDA has classified the action as Class II.

Incorrect image content affects the images a clinician reads during a procedure. The enforcement record reports no injuries. Facilities should follow Philips' instructions.

The recalled product

Product
Philips Azurion system; Software Version Number: R3.1;
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Interventional X-ray
Hazard
Affected units
228

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)

  • Software Version Number: R3.1
  • (1) Model Number: 722221
  • System Product Name: Azurion 3 M12
  • UDI-DI: 00884838099203
  • Serial Numbers: (2) Model Number: 722222
  • System Product Name: Azurion 3 M15
  • UDI-DI: 00884838099210
  • Serial Numbers: (3) Model Number: 722223
  • System Product Name: Azurion 7 M12
  • UDI-DI: 00884838099241
  • Serial Numbers: (4) Model Number: 722224
  • System Product Name: Azurion 7 M20
  • UDI-DI: 00884838099258
  • Serial Numbers: (5) Model Number: 722225
  • System Product Name: Azurion 7 B12
  • UDI-DI: 00884838099265
  • Serial Numbers: (6) Model Number: 722226
  • System Product Name: Azurion 7 B20
  • UDI-DI: 00884838099272
  • Serial Numbers: (7) Model Number: 722227

Distribution

Distributed in 9 states:

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