BEUDAMED
    FDA Recall Open, Classified

    Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)

    Recall: Z-0971-2024 · Initiated November 17, 2023

    Recall

    Recall Number
    Z-0971-2024
    Event Number
    93544
    Firm
    Draegerwerk Ag & Co. Kgaa Dragerwerk Ag & Co. Kgaa Accounts Payable Moislinger Allee
    FEI Number
    3001104093
    Product Code
    BSZ
    Status
    Open, Classified
    Root Cause
    Use error
    Initiated
    November 17, 2023
    Posted
    February 1, 2024
    Address
    53 55 Lubeck Germany

    Description

    Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)

    Reason

    Internal backup battery may fail spontaneously while the Atlan is being operated without AC mains supply, resulting in unexpected shutdown of the device while running on batteries.

    Action

    Draeger US was notified of the recall by their corporate office in Germany on November 17, 2023. All 50 units imported into the US at the time had not been distributed to end-users and were under the direct control of Draeger, Inc. Therefore, the firm did not issue a recall communication to customers. As a corrective action, an Instructions for Use (IFU) supplement has been added to these affected devices. The supplement outlines additional instructions regarding battery operation and inspection. Future shipments of Atlan devices will have the IFU supplement included with the device shipment.

    Distribution

    No devices were distributed to end-users (customers) in the US. All devices are currently under the direct control of Draeger, Inc.

    Quantity

    50 imported to US, not distributed to end users