Recall Z-0304-2025 · BSZ Gas-Machine, Anesthesia
Draeger Medical, Inc.
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
| Date | Nov 13, 2024 (initiated Oct 15, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | On October 15, 2024 Urgent Medical Device Correction letters were sent to customers. Necessary Action: The corrective action is to replace the ventilator motor assembly. You will be contacted by your local Draeger Service Representative to arrange a date for the ventilator motor assembly replacement. Until the corrective action is implemented, you may continue operating your devices with the customary care by only using the device under permanent supervision in line with the Atlan Instructions for Use. If the mechanical ventilation fails, use Man/Spont ventilation mode to ventilate the patient |
| Quantity | 1,492 units (139 units US, 1,353 OUS) |
| Distribution | US Nationwide distribution in the states of AL, AZ, CA, FL, GA, IA, IL, KY, MA, ME, ND, NE, NH, NJ, NY, OH, PA, TN, TX, WI, WY. International distribution: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chili, China, Columbia, Croatia, Czech Republi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K230931 | Atlan Drägerwerk AG Co. Kgaa, Jul 23, 2023 |