The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2503-2025·Announced 2025-09-10

Interventional imaging systems recalled because single phase UPS may fail on power loss

Philips Allura systems configured with a 1 Phase UPS are recalled because they may shut down and/or fail to start up if power to the system is lost. 1,006 units are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; an interventional imaging system that shuts down or fails to start could interrupt a procedure, and no injuries are reported.

Plain-English summary

Philips Allura systems configured with a 1 Phase Uninterruptible Power Supply are being recalled across the Allura family (R1.x, R2.x), including the Allura Xper FD10 (model 722003) and Allura Xper FD10/10 (model 722005), with serial numbers listed in the recall notice. The recall covers 1,006 units distributed nationwide in the United States and in many other countries.

Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply have the potential of shutting down and/or not starting up if power to the system is lost. The FDA classified the action as Class II.

Imaging sites operating these systems should follow the manufacturer's instructions for inspection and correction.

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.
Category
Medical Device — Imaging System
Hazard
Affected units
1,006

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.

Part of a larger recall action

This product is one of 2 recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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