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

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.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

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