Class II — Draegerwerk Ag & Co. Kgaa
| Recalling firm | Draegerwerk AG & Co. KGaA |
|---|---|
| Registered facility | Draegerwerk AG & Co. KGaA (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL) |
| Quantity | 50 imported to US, not distributed to end users |
| Distribution | No devices were distributed to end-users (customers) in the US. All devices are currently under the direct control of Draeger, Inc. |
| Initiated | 2023-11-17 |
| Classified | 2024-02-01 |
| Recall number | Z-0971-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Draegerwerk Ag & Co. Kgaa (Z-0971-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93544/
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