FDA DeviceClass IINotable

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

Date: 2026-06-03
Brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category: Medical Device
FDA Class: Class II

Description

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.

Hazard

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.

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