Recall Z-2617-2025 · BSZ Gas-Machine, Anesthesia
Draeger, Inc.
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified
| Date | Oct 1, 2025 (initiated Sep 9, 2025) |
| Status | Open, Classified |
| Reason | The device 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 09/09/2025, "URGENT MEDICAL DEVICE CORRECTION" letters were sent to customers. Actions to be taken: - The corrective action is for a Drger Service Representative to inspect, and, if necessary, replace the ventilator motor assembly. You will be contacted by your local Drger Service Representative to arrange a date for the ventilator motor assembly inspection and, if necessary, replacement. - Please ensure that all users of the Drger Atlan as well as other persons concerned within your organization are made aware of this Urgent Medical Device Correction notice. - Please complete and return th |
| Quantity | 223 |
| Distribution | Devices were imported from Draegerwerk Ag and Co. KGaA and distributed in the following states: AL, AZ, CA, CT, FL, GA, ID, IL, IN, KS, KY, MA, MN, MO, NC, NE, NM, NV, NY, OH, PA, TX, UT, VA, WI. Devices were direct shipped from Draegerwerk Ag and Co. KGaA to the following countries: Argentina, Aust |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K230931 | Atlan Drägerwerk AG Co. Kgaa, Jul 23, 2023 |