Atlan A350XL anesthesia workstations may fail during mechanical ventilation

Plain-English summary

The Atlan A350XL anesthesia workstation, model number 8621600, UDI-DI 04048675556183, is being recalled. The action covers 394 units, identified by the serial numbers in the recall notice.

The stated reason is that the Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. The FDA classified the action as Class I, its most serious classification.

Distribution was within the United States, in Wisconsin, Arkansas, Minnesota, Colorado, Massachusetts, Pennsylvania, Arizona, Florida, New York, South Dakota and North Dakota, and internationally. The workstations are installed in hospital operating rooms rather than sold to consumers.

Facilities should identify affected units using the model number, UDI-DI and serial numbers in the recall notice and follow the instructions issued by the manufacturer.

The recalled product

Product

Atlan A350XL. Model Number: 8621600. anesthesia workstation

Manufacturer

Draeger, Inc.

Category

Medical Device — Anesthesia workstation

Hazard

• ventilator-failure
• piston-ventilator
• class-i
• anesthesia

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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