Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Descri

FDA device recall Z-2616-2025 · posted 2025-10-01 · Open, Classified

Recall details

Recalling firm

Draeger, Inc.

Reason for recall

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

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

BSZ

Quantity affected

530

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. Devi

Date initiated

2025-09-09

Date posted

2025-10-01

Location

Telford, PA

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