Atlan A350 anesthesia workstations recalled after mechanical ventilation failures were reported

Plain-English summary

Atlan A350 anesthesia workstations, model/catalog number 8211500, are being recalled. The Atlan is an anesthesia workstation intended for use in anesthetizing adults, paediatric patients and neonates.

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

The recall covers 530 units carrying UDI-DI 04048675556176. The devices were imported from Draegerwerk AG and Co. KGaA and distributed across a list of US states including Alabama, Arizona, California and Connecticut. The FDA has classified the recall as Class I.

Hospitals operating affected serial numbers should follow Draeger's instructions and ensure a means of manual ventilation is immediately available wherever these workstations are in use.

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 workstation

Hazard

• ventilator-failure
• device-failure
• anesthesia
• loss-of-ventilation

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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