FDA Alerts Public to Expanded Draeger Anesthesia Machine Correction

The U.S. Food and Drug Administration (FDA) has issued an early alert regarding an expanded correction by Draeger, Inc. for its Atlan A350 and Atlan A350 XL anesthesia workstations. This action addresses a manufacturing error that could lead to the piston ventilator failing before or during use.

The error may prevent mechanical ventilation from starting or cause it to fail mid-procedure, triggering a "Ventilator error!!!" message. While manual ventilation or spontaneous breathing remains possible, the use of affected devices carries risks of serious adverse health consequences, including hypoxia, loss of lung recruitment, bradycardia, cardiac arrest, and death.

Draeger, Inc. has advised affected customers to correct these machines prior to continued use. This expanded correction follows a previous action initiated in October 2024. Customers with questions should contact Draeger Service Technical Support.