Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.
Device
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Recall record
Recall number
Z-0305-2025
Classification
Class I
Status
Ongoing
Voluntary or mandated
Voluntary: Firm initiated
Firm notification
Letter
Distribution
US Nationwide distribution in the states of AL, AZ, CA, FL, GA, IA, IL, KY, MA, ME, ND, NE, NH, NJ, NY, OH, PA, TN, TX, WI, WY. International distribution: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chili, China, Columbia, Croatia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Italy, Japan, Jordan, Kazakhstan, Kenya, Latvia, Malaysia, Mauritius, Mexico, Morocco, Namibia, Nepal, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Vietnam.
Recall initiated
2024-10-15
Classified by FDA Center
2024-11-13
FDA published
2024-11-20
Recalling firm
Draeger Medical, Inc.
Firm location
Telford, PA
Operational response
A Class I device recall indicates a strong likelihood of serious adverse
health consequence or death from continued use. Identify affected units
by serial number, lot, or GTIN against your inventory and against
implanted-device patient registry. Pull affected inventory from active
use immediately. For implanted devices, follow the recalling firm’s
patient-notification protocol; in most cases this requires informing
affected patients and their treating physicians directly.