# FDA recall Z-0971-2024

> **Draegerwerk Ag & Co. Kgaa** · Class II · device recall initiated 2023-11-17.

## 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

- **Recall number:** Z-0971-2024
- **Recalling firm:** Draegerwerk Ag & Co. Kgaa
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-17
- **Report date:** 2024-02-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lubeck, Germany

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0971-2024. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-0971-2024. Source: US FDA. Licensed CC0.

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