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  5. Anesthesia Machine Correction: Draeger, Inc., Issues Correction for Atlan A350 and A350 XL Anesthesia Workstations Due to Possible Mechanical Ventilation Failure
  1. Medical Device Recalls

Anesthesia Machine Correction: Draeger, Inc., Issues Correction for Atlan A350 and A350 XL Anesthesia Workstations Due to Possible Mechanical Ventilation Failure

This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.  

Affected Product

  • Product Names: Atlan A350 and Atlan 350XL anesthesia workstations
  • Unique Device Identifier (UDI)/Model:
  • Atlan A350: 04048675556176/8621500
  • Atlan A350 XL: 04048675556183/8621600
  • Lot/Serial Numbers: See full list of affected devices

What to Do

Until Draeger, Inc. can replace the ventilator motor assembly:

  • Use these devices with close, constant supervision.
  • Ventilate patients manually by switching to manual/spontaneous (Man/Spont) mode if mechanical ventilation fails.

On October 15, 2024, Draeger, Inc., sent all affected customers an Urgent Medical Device Correction noting that a Draeger representative will be in contact to arrange for a ventilator motor assembly replacement. The letter also recommended the following actions until the correction can be made:

  • Continue using devices under permanent supervision (in line with the 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 injury.
  • If preferred, downgrade the alarm priority of the "Ventilator error!!!" to "ALARM RESET" after switching to Man/Spont ventilation mode.
  • Make sure all users of the Draeger Atlan and others in the organization with concern for this device know about the notice.
  • Complete and return the Medical Device Correction Return Response Acknowledgment and Receipt Form attached to the letter, confirming that the information was received.
  • Forward the notice to any third parties who may have received these products.

Reason for Correction

Draeger, Inc., is correcting Atlan A350 and A350 XL anesthesia workstations due to a manufacturing error that may cause the piston ventilator to fail before use or mechanical ventilation to fail during use.

The use of affected product may cause serious adverse health consequences, including lack of oxygen (hypoxia), loss of the ability to expand the lungs (lung recruitment), slow heart rate (bradycardia), sudden heart stop (cardiac arrest), and death.

There have been no reported injuries. There have been no reports of death.  

Device Use

The Atlan A350 and A350 XL anesthesia workstations are intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. It is used for inhaled anesthesia during surgical or diagnostic procedures. 

Contact Information

Customers in the U.S. with questions about this recall should contact Draeger, Inc. Service Technical Support at 1-800-437-2437 (option 2 at the prompt, then 2, then 2 again).

Full List of Affected Devices

Additional FDA Resources

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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