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.
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 A350 is an anesthesia workstation used to deliver inhalational anesthesia and to ventilate patients during surgery or diagnostic procedures. It is designed for adults, pediatrics, and neonates. The device supports mechanical ventilation and spontaneous breathing modes.
A piston ventilator failure before use or a failure during mechanical ventilation can compromise patient ventilation and safety during anesthesia.
This recall is not described as part of a broader industry pattern in the provided notice.
Hospitals may need to quarantine affected units and switch to alternative ventilation methods until replacements or repairs are arranged. The recall covers 530 units across multiple states and many countries, indicating a significant distribution footprint.
Model numbers and serial numbers appear on the device label and in the device documentation; UDI-DI may be listed in the recall notice.
Recall remediation and potential replacement or service actions are typically outlined by the manufacturer; timelines vary by institution.
Keep copies of the recall notice, manufacturer instructions, device serial numbers, and all correspondence with the vendor.
Model/Catalog Number: 8211500. Quantity: 530 units. Distribution: 25 U.S. states listed; addresses include AL, AZ, CA, CT, FL, GA, ID, IL, IN, KS, KY, MA, MN, MO, NC, NE, NM, NV, NY, OH, PA, TX, UT, VA, WI. Exports: 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. Imported from Draer?
No injuries or incidents have been reported.
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