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Draegerwerk Ag & Co. Kgaa recalls Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
Recalled February 7, 2024 · FDA recall Z-0971-2024 · Draegerwerk Ag & Co. Kgaa
Hazard
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. · FDA Class II
Units
50 imported to US, not distributed to end users
Sold at
No devices were distributed to end-users (customers) in the US. All devices are currently under the direct control of Draeger, Inc.
Description
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)
Manufacturer(s)
Draegerwerk Ag & Co. Kgaa
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →