The Recall Desk
HighFDA (Devices)·Z-1079-2026·Announced 2026-01-21

[pending] Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models:

Pending LLM rewrite. Source: FDA_DEVICE Z-1079-2026.

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: Pending LLM scoring against the rubric.

Plain-English summary

Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.

The recalled product

Product
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5.
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Devices

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)

  • (01)00884838116726(21)15
  • (01)00884838116726(21)16
  • (01)00884838116726(21)6
  • (01)00884838116726(21)8
  • (01)00884838116726(21)4
  • (01)00884838116726(21)24
  • (01)00884838116726(21)26
  • (01)00884838116726(21)20
  • (01)00884838116726(21)25
  • (01)00884838116726(21)11
  • (01)00884838116726(21)21
  • (01)00884838116726(21)13
  • (01)00884838116726(21)7
  • (01)00884838116726(21)10
  • (01)00884838116726(21)2
  • (01)00884838116726(21)3
  • (01)00884838116733(21)40
  • (01)00884838116733(21)9
  • (01)00884838116733(21)1
  • (01)00884838116733(21)38

Distribution

Distributed nationwide across the United States.

Related recalls

Same category