FDA DeviceClass IINotable

FDA Recall: Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura

Date: 2026-08-12
Brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category: Medical Device
FDA Class: Class II

Description

Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

Hazard

Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

Remedy

5,012 units

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