FDA Device recall Z-0668-2025
Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anest…
- FDA Device
- Class I
- ongoing
- Published 2024-12-25
On 2024-12-25 the FDA classified a Class I recall of Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anest… by Draeger Medical, citing the Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0668-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-10-15 |
| Published | 2024-12-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Draeger Medical |
| Distribution | n/a |
Product
Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
Reason
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Identifiers
| code_info | Model/Catalog Number: 8621400; UDI-DI Number: 04048675556343; Serial Numbers shipped directly from Draegerwerk AG & Co.…Model/Catalog Number: 8621400; UDI-DI Number: 04048675556343; Serial Numbers shipped directly from Draegerwerk AG & Co., KGaA to OUS: ASTB-0051; 0053; 0054; 0055; 0063; 0065; 0093; 0162 ASTE-0219; 0220; 0221; 0222; 0377 ASTF-0472; 0473 ASTH-0005; 0006; 0026; 0027; 0047; 0186; 0223; 0224; 0401 ASTJ-0170 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0668-2025%22
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