The Recall Desk
HighFDA (Devices)·Z-2229-2026·Announced 2026-05-27

Integris-Allura X-ray systems with degraded deaeration hoses recalled

Philips is recalling Integris-Allura X-ray systems because deaeration hoses in X-ray tube cooling units may degrade, causing oil leakage that reduces cooling performance and triggers a system shutdown to low-dose mode.

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: This is an FDA Class II recall of a medical device with a risk-of-harm condition (oil leakage affecting X-ray tube cooling and system function), but the source text does not report any illnesses, injuries, or hospitalization events associated with the hazard. Under the rubric, risk-of-harm medical devices without reported injury warrant a High severity score.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling multiple models of Integris-Allura X-ray systems that contain type CU3101 X-ray tube cooling units manufactured between February 2016 and May 2020. The deaeration hose in these cooling units may degrade over time, potentially resulting in oil leakage.

Oil leakage may affect the cooling performance of the X-ray tube. When oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message "Low load fluoroscopy flavor selected: Tube cooler problem." This condition cannot be resolved by restarting the system.

Approximately 25 units are affected: 11 in the United States and 14 distributed internationally across numerous countries including Canada, Australia, Japan, Germany, United Kingdom, and others. Healthcare facilities using affected Integris-Allura systems should contact Philips for guidance on inspection and remediation of the cooling units.

Consumers and healthcare professionals should report any adverse events related to this recall to the FDA's MedWatch program.

The recalled product

Product
Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integris Allura 15 & 12 (monoplane) (722043), INTEGRIS Allura 15-12 (biplane) (722044), Integris-Allura 9 (722018), Integris-Allura 9 (Biplane) (722021), Integris CV
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Diagnostic imaging / X-ray systems
Hazard

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. Integris CV Cesar-Powerpack-Visub-Nicol
  • Model: 722030
  • UDI-DI: N/A
  • Serial Numbers: 4888270
  • 59
  • 0
  • 33
  • 2. Integris Allura 15 & 12 (monoplane) (722043)
  • Serial Numbers: 365
  • 18151
  • 176
  • 239
  • 407
  • 426
  • 3. INTEGRIS Allura 15-12 (biplane) (722044)
  • Serial Numbers: 86322
  • 30
  • 66
  • 4. Integris-Allura 9 (722018)
  • Serial Numbers: 26

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Related recalls

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

See all →

Same hazard · oil leakage

See all →