The Recall Desk
HighFDA (Devices)·Z-0238-2022·Announced 2021-12-01

Philips Azurion System Recall for 3D Image Reconstruction Defect

Philips Healthcare is recalling Azurion systems with software releases 2.1(L1) and 2.1(L2) due to a software defect that prevents proper reconstruction of 3D X-ray images when the detector is positioned outside required tolerance.

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: FDA Class II device with a software defect preventing proper 3D image reconstruction. No injuries or adverse events have been reported. As a medical imaging device with potential for diagnostic error, it represents a risk-of-harm product where injury has not yet been reported, meeting the criterion for High severity.

Plain-English summary

Philips Healthcare is recalling Azurion X-ray systems with software releases 2.1(L1) and 2.1(L2). These systems include 3D reconstruction software (3D-RA) that enables 3D X-ray imaging. The recall affects 226 units distributed nationwide.

The software defect involves detector positioning tolerance. For 3D scans, the Azurion's detector must be positioned at exactly 0 or +/-90 degrees relative to the 3D scan direction. The software incorrectly allows the detector to be positioned with a deviation of up to 3 degrees. However, 3D scans acquired with a detector deviation greater than 1.0 degree cannot be reconstructed by the 3D-RA software, resulting in failed or unusable images.

This defect creates a mismatch between allowed detector positioning (up to 3 degrees) and successful reconstruction capability (within 1 degree). Operators may acquire 3D scans that cannot be properly reconstructed. No injuries or adverse events have been reported. Philips recommends that owners and operators contact them for information about obtaining a software update to correct this issue.

The recalled product

Product
Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
Manufacturer
Philips Healthcare
Category
Medical Device — Imaging Equipment
Hazard
Affected units
226

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 (1)

  • Azurion 2.1(L1) and 2.1(L2)

Distribution

Distributed nationwide across the United States.

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