Draeger Medical, Inc.: Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neona

Hazard

The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

Details from the source

Reason for recall: The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. Distribution: No Atlan A300 or A300XL devices were imported into the US. Devices were direct shipped from Draegerwerk Ag and Co. KGaA to the following countries: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chili, China, Colombia, Croatia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Italy, Quantity: 25 units (OUS Only) Lot/code info: Model/Catalog Number: 8621400; UDI-DI Number: 04048675556343; Serial Numbers shipped directly from Draegerwerk AG & Co., KGaA to OUS: ASTB-0051; 0053; 0054; 0055; 0063; 0065; 0093; 0162 ASTE-0219; 0220; 0221; 0222; 0377 ASTF-0472; 0473 ASTH-0005; 0006; 0026; 0027; 0047; 0186; 0223; 0224; 0401 ASTJ-0170

UPC codes

04048675556343

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.