CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Affected Product
The FDA is aware that Draeger, Inc. has issued a letter to affected customers recommending certain anesthesia Machine be corrected prior to continued use. Affected devices:
- 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: Full list of affected devices.
What to Do
Until Draeger, Inc. can replace the ventilator motor assembly use these devices with close, constant supervision. On May 7, Draeger, Inc. sent all affected customers a letter recommending the following actions:
- Customers may continue using devices under permanent supervision until the ventilator motor assembly can be replaced
- 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.
- Forward the notice to any third parties who may have received these products.
Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Reason for Alert
Draeger, Inc., is expanding their October 2024 correction to include additional Atlan A350 and A350 XL anesthesia workstations. This correction is due to a manufacturing error that may cause the piston ventilator to fail before use or mechanical ventilation to fail during use.
If the error occurs before use, such as in standby or system test mode, mechanical ventilation cannot be started. If the error occurs during a procedure, the mechanical ventilation may fail, and the device alerts the user by displaying the “Ventilator error!!!” message. Manual ventilation or spontaneous breathing remains possible in both cases. It may be necessary to manually ventilate the patient to prevent injury. With the ongoing alarm of the ventilation failure, the Atlan continues to provide the Man/Spont ventilation mode, fresh-gas and agent delivery as well as all monitoring functions without restriction.
Draeger will replace the ventilator motor assembly on affected devices. Customers will be contacted by their local Draeger Service Representative to arrange a date for the ventilator motor assembly replacement.
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. As of May 6, 2026, there have been no reported injuries and 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 adverse reactions, quality problems, or questions about this issue should contact Draeger Service Technical Support at 1-800-437-2437.
Additional FDA Resources
1 Anesthesia Machine Correction: Draeger, Inc., Issues Correction for Atlan A350 and A350 XL Anesthesia Workstations Due to Possible Mechanical Ventilation Failure | FDA [11/19/2024]
2 FDA Enforcement Report – 11/2024 recall
3 CDRH Medical Device Recalls Database – 11/2024 recall
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database – Identify Your Medical Device
- Benefits of a UDI System
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.
