The Recall Desk
HighFDA (Devices)·Z-1144-2024·Announced 2024-02-28

Philips Allura Xper Interventional X-ray System Display and Imaging Malfunction

A framegrabber card malfunction in Philips Allura Xper interventional X-ray systems may cause display failures, preventing proper visualization of medical images and delaying procedures.

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 FDA Class II medical device recall involves a functional failure that could impair imaging during medical procedures. No injuries, illnesses, or deaths have been reported, satisfying the criterion for score 3: risk-of-harm without documented adverse events.

Plain-English summary

Philips Allura Xper Interventional Fluoroscopic X-ray Systems are being recalled due to a potential framegrabber card malfunction in the PC component. The card controls image display on the monitor. When it malfunctions, the monitor may fail to display any viewports, display no image, show a distorted image, or show a frozen image. Additionally, switching between viewports on the monitor may not be possible.

Approximately 1,993 systems have been distributed in the United States and 2,662 systems distributed outside the United States. The recall affects multiple Allura Xper models, including FD10, FD10/10, FD20, FD20 Biplane, FD20 OR Table, FD20/10, FD20/15, FD20/15 OR Table, FD20/20, and FD20/20 OR Table models. Affected systems are identified by specific serial numbers and UDI codes provided in the official FDA recall notice.

The framegrabber card malfunction can prevent healthcare providers from properly visualizing medical images during interventional procedures, which may result in procedural delays. This functional failure poses a risk to the continuity and quality of medical care.

Affected healthcare facilities should refer to the official FDA recall notice and contact the manufacturer for guidance on remediation options.

The recalled product

Product
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — Interventional Imaging / Fluoroscopy
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 (6)

  • 722012 - UDI-DI 00884838059054
  • 00884838059191
  • 722028 - UDI-DI 00884838054202
  • Allura Xper FD20 Biplane OR Table 722025 - no UDI Serial Numbers 2 3
  • Allura Xper FD20/15 OR Table 722059 - UDI-DI 00884838059122 Serial Numbers 33 7
  • Allura Xper FD20/20 OR Table 722039 - No UDI Serial Number 3

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 →

Related recalls

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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Same hazard · image display failure

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