The Recall Desk
Severity pendingFDA (Devices)·Z-2259-2026·Announced 2026-06-03

Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), A

Pending LLM rewrite. Source: FDA_DEVICE Z-2259-2026.

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

It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.

The recalled product

Product
Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allur
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)

  • 1. Allura Xper FD10
  • Model: 722003
  • UDI-DI: N/A
  • Serial Numbers: 445
  • 1555
  • 1114
  • 1529
  • 472
  • 1349
  • 1594
  • 1311
  • 1472
  • 1187
  • 1700
  • 1031
  • 912
  • 913
  • 940
  • 285
  • 1637

Distribution

Distributed nationwide across the United States.

Related recalls

Same category