Recall Z-2207-2026 · BSZ Gas-Machine, Anesthesia
Draeger, Inc.
Atlan A350. Model Number: 8211500. anesthesia workstation
| Date | Jun 4, 2026 (initiated May 7, 2026) |
| 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 change control |
| Action | Draeger notified consignees of the recall update and expansion on about 05/07/2026 via emailed letter titled Urgent Medical Device Correction Update. Consignees were made aware that due to continuous monitoring, Draeger has determined that an additional number of Atlan devices are affected by the issue and they are replacing ventilator motors. Consignees were instructed that a Draeger Service Representative will contact consignees to arrange a date for the ventilator motor assembly replacement, and until the corrective action is implemented, the device may continue to be used with the custo |
| Quantity | 3,515 units |
| Distribution | US distribution in WI, AR, MN, WI, CO, MA, PA, AZ, FL, NY, SD, ND. International distribution to: Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chili, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, Fran |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K230931 | Atlan Drägerwerk AG Co. Kgaa, Jul 23, 2023 |