FDA-Device2024-02-07Class II
Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
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.
Sold states
No devices were distributed to end-users (customers) in the US. All devices are currently under the direct control of Draeger, Inc.
Affected count
50 imported to US, not distributed to end users
Manufactured in
Dragerwerk Ag & Co. Kgaa Accounts Payable, Moislinger Allee 53 -55, Lubeck, Germany
Products
Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0971-2024Don't want to check this manually?
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