Lubeck, Germany
Draegerwerk Ag & Co. Kgaa recalls
1 recall recorded since 2018, most recently on 17 November 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 17 November 2023
- 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.
- Distribution
- No devices were distributed to end-users (customers) in the US. All devices are currently under the direct control of Draeger, Inc.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0971-2024
- Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.