BEUDAMED
    FDA Recall Open, Classified

    Atlan A350XL. Model Number: 8621600. anesthesia workstation

    Recall: Z-2208-2026 · Initiated May 7, 2026

    Recall

    Recall Number
    Z-2208-2026
    Event Number
    98914
    Firm
    Draeger, Inc.
    FEI Number
    2517967
    Product Code
    BSZ
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    May 7, 2026
    Posted
    June 4, 2026
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    Description

    Atlan A350XL. Model Number: 8621600. anesthesia workstation

    Reason

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

    Action

    Draeger notified consignees of the recall update and expansion on about 05/07/2026 via emailed letter titled Urgent Medical Device Correction Update. Consignees were made aware that due to continuous monitoring, Draeger has determined that an additional number of Atlan devices are affected by the issue and they are replacing ventilator motors. Consignees were instructed that a Draeger Service Representative will contact consignees to arrange a date for the ventilator motor assembly replacement, and until the corrective action is implemented, the device may continue to be used with the customary care by only using the device under permanent supervision in line with the Atlan Instructions for Use. If the mechanical ventilation fails, use Man/Spont ventilation mode to ventilate the patient manually as needed. Consignees were also instructed to complete and return the provided Medical Device Correction Return Response Acknowledgment and Receipt Form and if products have been made available to third parties, please forward this Urgent Medical Device Correction notice to them.

    Distribution

    US distribution in WI, AR, MN, WI, CO, MA, PA, AZ, FL, NY, SD, ND. International distribution to: Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chili, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Gabon, Germany, Ghana, Greece, Greenland, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Italy, Israel, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Martinique, Mauritius, Mexico, Morocco, Mozambique, Namibia, Nepal, Netherlands, Norway, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Uzbekistan, Venezuela, Vietnam, Yemen

    Quantity

    394 units