Atlan A350 Anesthesia Workstation Ventilator Failure Class I Recall

Plain-English summary

Draeger, Inc. is recalling approximately 530 Atlan A350 anesthesia workstations (Model 8211500) due to critical failure of the piston ventilator mechanism. The device may either indicate a failure before use or experience failure of mechanical ventilation during active patient care.

The Atlan A350 is an anesthesia workstation designed for use with adult, pediatric, and neonatal patients during surgical and diagnostic procedures. It supports multiple ventilation modes including mechanical ventilation, manual ventilation, and spontaneous breathing support.

Affected devices were distributed to hospitals and surgical facilities across multiple U.S. states and to healthcare facilities in numerous countries worldwide. The FDA has classified this as a Class I recall, the agency's most serious safety designation. Healthcare facilities and anesthesia providers should verify their equipment serial numbers against the manufacturer's recall list and contact Draeger for further instructions on device status and any necessary corrective actions.

The recalled product

Product

Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical vent

Manufacturer

Draeger, Inc.

Category

Medical Device — Anesthesia Equipment / Ventilator

Hazard

• ventilator-failure
• mechanical-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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