Draeger recalls 223 Atlan A350XL anesthesia workstations distributed in 25 states and many countries after reports of piston ventilator failure and mechanical ventilation failures. The recall affects units imported from Draegerwerk AG and Co. KGaA. Stop using the device immediately. Contact Draeger for instructions and patient safety guidance.
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 Atlan A350XL is an anesthesia workstation used to ventilate patients during surgical or diagnostic procedures. It supports mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing, for adults, pediatric, and neonatal patients.
A piston ventilator failure before use or a mechanical ventilation failure during operation can result in inadequate ventilation during anesthesia, potentially harming patients.
This recall is not described as part of a broader industry pattern in the data provided.
Health systems may need to replace or repair affected workstations promptly to avoid procedural delays and ensure safe patient ventilation.
Serial numbers/UDI can be found on the equipment label and accompanying documentation.
Remedy timelines are not specified; follow Draeger recall instructions for expected replacement or field actions.
Keep copy of the recall notice, serial numbers, purchase records, and all correspondence with Draeger.
Brand: Draeger. Product: Atlan A350XL anesthesia workstation. Model/Catalog Number: 8621600. Distribution: 25 US states listed; international distribution to Argentina, Australia, Belgium, Brazil, Chile, China, Croatia, Denmark, Ecuador, France, Georgia, Germany, Greece, Hungary, India, Indonesia, Italy, Japan, Jordan, Kuwait, Lithuania, Mexico, Netherlands, Peru, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Vietnam. Quantity: 223 units.
No injury counts or incident narratives are provided in the recall notice beyond the class I designation and the stated hazard. No specific injuries or deaths are mentioned in the available data.
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Drӕager recalled 530 Atlan A350 anesthesia workstations imported from Draegerwerk AG and Co. KGaA and distributed to 25 U.S. states and more than 30 countries. The device can experience a piston ventilator failure before use or fail to ventilate during use. Hospitals should stop using affected units immediately and follow Draeger recall instructions.