The Recall Desk
HighFDA (Devices)·Z-1091-2026·Announced 2026-01-21

[pending] Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label des

Pending LLM rewrite. Source: FDA_DEVICE Z-1091-2026.

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

Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error.

The recalled product

Product
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3 M15. Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12. Model Num
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)00884838085275(21)64
  • (01)00884838085275(21)56
  • (01)00884838085275(21)131
  • (01)00884838085275(21)84
  • (01)00884838085275(21)132
  • (01)00884838085275(21)96
  • (01)00884838085275(21)98
  • (01)00884838085275(21)108
  • (01)00884838085275(21)153
  • (01)00884838085275(21)69
  • (01)00884838085275(21)154
  • (01)00884838085275(21)97
  • (01)00884838085275(21)137
  • (01)00884838085275(21)116
  • (01)00884838085275(21)127
  • (01)00884838085275(21)151
  • (01)00884838085275(21)148
  • (01)00884838085275(21)150
  • (01)00884838085275(21)146
  • (01)00884838085275(21)149

Distribution

Distributed nationwide across the United States.

Related recalls

Same category