Brand Name: Atlan recallZ-0305-2025 · Draeger Medical, Inc. · initiated Oct 15, 2024

Why it was recalled

The Atlan anesthesia workstation 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 October 15, 2024 Urgent Medical Device Correction letters were sent to customers. Necessary Action: The corrective action is to replace the ventilator motor assembly. You will be contacted by your local Draeger Service Representative to arrange a date for the ventilator motor assembly replacement. Until the corrective action is implemented, you may continue operating your devices with the customary care by only using the device under permanent supervision in line with the Atlan Instructions for Use. If the mechanical ventilation fails, use Man/Spont ventilation mode to ventilate the patient manually as needed. Monitor the patient s condition specifically their oxygenation status as a brief cessation of ventilation can potentially lead to e.g.; hypoxia, loss of lung recruitment, bradycardia and cardiac arrest. If preferred, the alarm priority of the "Ventilator error!!!" can be downgraded with "ALARM RESET" after switching to Man/Spont ventilation mode. Identification of affected medical devices: According to our records, you have received at least one Atlan anesthesia workstation manufactured by Draegerwerk AG & Co. KGaA that may be affected by this issue. Please refer to the attached list of affected serial numbers. 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 Draeger 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

Recall details

Recall number

Z-0305-2025

Status

Open, Classified

Initiated by the company

Oct 15, 2024

Posted by the FDA

Nov 13, 2024

Recalling firm

Draeger Medical, Inc.

Quantity

455 units (310 units US, 145 OUS)

Product code

BSZ

FDA submissions

K230931

Distribution

US Nationwide distribution in the states of AL, AZ, CA, FL, GA, IA, IL, KY, MA, ME, ND, NE, NH, NJ, NY, OH, PA, TN, TX, WI, WY. International distribution: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chili, China, Columbia, Croatia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Italy, Japan, Jordan, Kazakhstan, Kenya, Latvia, Malaysia, Mauritius, Mexico, Morocco, Namibia, Nepal, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Vietnam.

Product description

Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable 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 95561).

• Z-0304-2025 · Open, Classified
  Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable