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

FDA device recall Z-0304-2025 · posted 2024-11-13 · Open, Classified

Recall details

Recalling firm

Draeger Medical, Inc.

Reason for recall

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

Action taken

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

Root cause

Process control

Status

Open, Classified

Product code

BSZ

Quantity affected

1,492 units (139 units US, 1,353 OUS)

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, B

Date initiated

2024-10-15

Date posted

2024-11-13

Location

Telford, PA

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