FDA DeviceClass INotable

FDA Recall: Atlan A350. Model Number: 8211500. anesthesia workstation

Date: 2026-06-10
Brand: Draeger, Inc.
Category: Medical Device
FDA Class: Class I

Description

The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

Hazard

The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

Remedy

3,515 units

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