FDA recall Z-0971-2024

Draegerwerk Ag & Co. Kgaa · Class II · device

Product

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

Reason for recall

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2023-11-17
Report date
2024-02-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lubeck, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0971-2024