Draeger, Inc. — Class I: Atlan A350XL. Model Number: 8621600. anesthesia workstation
Draeger, Inc. initiated a Class I recall for the Atlan A350XL anesthesia workstation (Model 8621600) due to reports of piston ventilator failures. These failures occurred either as a system notification prior to use or as a cessation of mechanical ventilation during active clinical use.
This recall affects Draeger, Inc., healthcare facilities utilizing Atlan A350XL anesthesia workstations, and clinical teams responsible for intraoperative ventilation and device maintenance.
A Class I designation indicates the FDA's assessment that the device defect carries a high risk of serious adverse health consequences or death. The failure of mechanical ventilation during a procedure presents an immediate risk of hypoxia or respiratory compromise. From a regulatory perspective, this suggests a critical reliability issue with the workstation's pneumatic or electronic control components that may require significant corrective action or hardware replacement.
Immediate identification and quarantine of affected Model 8621600 units is necessary. QA teams should review maintenance logs for piston ventilator error codes and ensure clinical staff are trained on manual ventilation protocols should a mechanical failure occur mid-procedure.
Class I. Reason: The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.. Product: Atlan A350XL. Model Number: 8621600. anesthesia workstation. Firm: Draeger, Inc. (Telford PA United States). Status: Ongoing.
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