The FDA is aware that Draeger, Inc. has issued a letter to affected customers recommending certain anesthesia Machine be corrected prior to continued use. 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.
Date of last update: May 15, 2026