The Recall Desk
HighFDA (Devices)·Z-2189-2025·Announced 2025-08-06

Philips Allura X-ray Systems Software Issue Causes Temporary Imaging Loss

Philips Allura R8.2.x fluoroscopy systems may experience temporary loss of X-ray imaging functionality due to a software issue. The recall affects 4,508 units distributed worldwide.

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 a Class II FDA recall of medical imaging devices with potential for temporary loss of critical functionality. No injuries or illnesses have been reported, and the hazard is theoretical. Per the rubric, recalls with risk-of-harm to patients where injury has not yet been reported are classified as High, which is the maximum score for recalls with no reported injuries and theoretical hazards.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling the Allura R8.2.x Systems, a line of fluoroscopy imaging devices. The recall affects 4,508 units distributed worldwide, including throughout the United States.

The affected devices may experience temporary loss of X-ray imaging functionality due to a software issue in the R8.2.x software version.

Healthcare facilities with affected equipment should contact Philips Medical Systems for information regarding remediation options for this issue.

The recalled product

Product
Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table,
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Fluoroscopy / Diagnostic Imaging
Hazard
  • software-malfunction
  • imaging-loss
  • temporary-dysfunction

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)00884838054189(21)156
  • (01)00884838054189(21)253
  • (01)00884838054189(21)287
  • (01)00884838054189(21)825
  • (01)00884838054189(21)394
  • (01)00884838054189(21)713
  • (01)00884838054189(21)465
  • (01)00884838054189(21)74
  • (01)00884838054189(21)462
  • (01)00884838054189(21)192
  • (01)00884838054189(21)191
  • (01)00884838054189(21)522
  • (01)00884838054189(21)204
  • (01)00884838054189(21)155
  • (01)00884838054189(21)1132
  • (01)00884838054189(21)967
  • (01)00884838054189(21)205
  • (01)00884838054189(21)1246
  • (01)00884838054189(21)122
  • (01)00884838054189(21)259

Distribution

Distributed nationwide across the United States.

Related recalls

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