Atlan A350XL anesthesia workstations recalled after piston ventilator failures during use

Plain-English summary

Atlan A350XL anesthesia workstations, model/catalog number 8621600, are being recalled. The Atlan is an anesthesia workstation intended for use in anesthetizing adults, paediatric patients and neonates, and supports mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing and spontaneous breathing during surgical or diagnostic interventions.

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 223 units carrying UDI-DI 04048675556183. The devices were imported from Draegerwerk AG and Co. KGaA and distributed to Alabama, Arizona, California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New Mexico, Nevada, New York, Ohio, Pennsylvania, Texas, Utah, Virginia and Wisconsin, with additional direct shipments to other countries. 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 A350XL Model/Catalog Number: 8621600 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 ve

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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