The FDA has classified a Dr\u00e4ger correction for Atlan A350 and Atlan A350 XL anesthesia machines as Class I, its most serious recall category. A manufacturing error may cause the piston ventilator to fail, either before use or in the middle of a procedure. The action expands a correction first issued in October 2024 to cover more units.<\/p>\n
If the ventilator fails, the machine shows a “Ventilator error” alarm and mechanical ventilation stops. Manual ventilation and spontaneous breathing remain possible, but the FDA warns that a failure can lead to hypoxia, loss of lung inflation, bradycardia, cardiac arrest or death. Dr\u00e4ger will repair devices in the field by replacing the ventilator motor assembly, and no injuries had been reported when the notice was published.<\/p>\n
Why it matters:<\/strong> an anesthesia machine has to be verified against its ventilation specification before it is put back into service, and again after any repair. Independent flow and pressure checks with a calibrated analyzer are the practical way to confirm delivered volume and pressure after a motor assembly swap.<\/p>\n