FDA DeviceClass IINotable

FDA Recall: Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below pro

Date: 2026-05-27
Brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category: Medical Device
FDA Class: Class II

Description

Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.

Hazard

Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.

Remedy

5,537 units

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