Draegerwerk Ag & Co. Kgaa recalls Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)

Recall date

November 17, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0971-2024

FDA classification

Class II

Brand / firm

Draegerwerk Ag & Co. Kgaa

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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