Drug recall
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable…
FDA recall event 95561 · Class I · Draeger Medical, Inc.
Key facts
| Event ID | 95561 |
|---|---|
| Recall numbers | Z-0304-2025, Z-0305-2025 |
| Recalling firm | Draeger Medical, Inc. |
| Product type | Devices |
| Products | Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable, Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. |
| Initiation date | Oct 15, 2024 |
| Report date | Nov 20, 2024 |
| City | Telford |
| State | PA |
| Country | United States |
| FEI number | 2517967 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: