Draeger recalled 530 Atlan A350 anesthesia workstations due to potential ventilation failures. The recall occurred on September 9, 2025, after reports of critical device malfunctions during use. Patients and healthcare providers must stop using the device immediately.
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Draeger, Inc. or your healthcare provider for instructions. Notification method: Letter
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The recalled model is the Atlan A350 with catalog number 8211500. The devices were imported from Draegerwerk Ag and Co. KGaA and distributed in states across the U.S. and internationally.
The Atlan A350 may indicate a failure of the piston ventilator before use or experience a mechanical failure during operation. These issues pose a high risk of inadequate patient ventilation.
No specific injury or incident numbers were reported. The potential failure of ventilation could lead to serious health consequences for patients.
Stop using the Atlan A350 immediately. Follow the recall instructions provided by Draeger, Inc. Contact your healthcare provider or Draeger for further instructions.
Consumers can reach Draeger, Inc. for further details. Visit the official FDA website for more information on the recall.
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