FDA DeviceClass IINotable

FDA Recall: Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 68

Date: 2026-08-12
Brand: Maquet Critical Care AB
Category: Medical Device
FDA Class: Class II

Description

Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient anesthesia and may lead to intraoperative awareness.

Hazard

Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient anesthesia and may lead to intraoperative awareness.

Remedy

408 US; 11,342 OUS

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