Atlan A350 (Draeger) – Mechanical Ventilation Failure (2025)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

Recommended Action

Per FDA guidance

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 the attached Medical Device Correction Return Response Acknowledgment and Receipt Form to confirm that you have received this information. - If you have made the products available to third parties, please forward this Urgent Medical Device Correction notice to them. If you have any questions regarding the operation of your Atlan A350/A350XL anesthesia workstation, please contact Drger Service Technical Support between the hours of 8:00 AM 8:00 PM EST at 1-800-437-2437 (press 2 at the prompt, then 2, then 2 again). If you have any questions regarding this Urgent Medical Device Correction notice, please contact Michael Kelhart between the hours of 8:00 AM 4:30 PM EST at 267-664-1131 or via email at mike.kelhart@draeger.com. Adverse events or quality problems experienced with the use of this product may be reported to FDA s MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm or by phone at 1-800-FDA-1088.

Distribution

As reported by FDA

AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, MA, MN, MO, NE, NV, NM, NY, NC, OH, PA, TX, UT, VA, WI