Brand Name: Atlan recallZ-2617-2025 · Draeger, Inc. · initiated Sep 9, 2025

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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 [email protected]. 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.

Recall details

Recall number

Z-2617-2025

Status

Open, Classified

Initiated by the company

Sep 9, 2025

Posted by the FDA

Oct 1, 2025

Recalling firm

Draeger, Inc.

Quantity

223

Product code

BSZ

FDA submissions

K230931

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, Australia, Belgium, Brazil, Chili, China, Croatia, Denmark, Ecuador, France, Georgia, Germany, Greece, Hungary, India, Indonesia, Italy, Japan, Jordan, Kuwait, Lithuania, Mexico, Netherlands, Peru, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Vietnam.

Product description

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 for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions Component: Not applicable

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Atlan A350 XL 8621600

  Drägerwerk AG & Co. KGaA · Gas-Machine, Anesthesia
  4 recalls1 death14 reports

Other devices under the same FDA submission

1 device cleared under K230931 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• Atlan A350 8621500

  Drägerwerk AG & Co. KGaA · Gas-Machine, Anesthesia
  4 recalls63 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 97525).

• Z-2616-2025 · Open, Classified
  Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for u…