The Recall Desk
Severity pendingFDA (Devices)·Z-2503-2025·Announced 2025-09-10

Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the

Pending LLM rewrite. Source: FDA_DEVICE Z-2503-2025.

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

Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.

The recalled product

Product
Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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 Number/System Code (UDI)
  • Serial Numbers: 722003 (No UDI)
  • 1225
  • 789
  • 1138
  • 445
  • 740
  • 152
  • 1411. 2. Model Number/System Code (UDI)
  • Serial Numbers: 722005 (No UDI)
  • 35. 3. Model Number/System Code (UDI)
  • Serial Numbers: 722006 (No UDI)
  • 168
  • 2198
  • 2184
  • 2606
  • 195
  • 161
  • 1956
  • 2256

Distribution

Distributed nationwide across the United States.