Draeger Medical, Inc. has recalled approximately 1,947 Atlan A350 and A350XL anesthesia workstations because the piston ventilator may fail to start before use or may fail during mechanical ventilation. These devices are used in hospitals and surgical centers to provide anesthesia and breathing support to patients during medical procedures. While no injuries have been reported, a failure of the ventilator can result in a loss of breathing support, requiring immediate intervention by medical staff to manually ventilate the patient. The recall affects units sold nationwide across 21 states and distributed internationally.
The mechanical ventilator in the anesthesia workstation may stop working or fail to initiate, potentially leaving a patient without mechanical breathing assistance during a surgical procedure. If this occurs, medical staff must immediately switch to manual ventilation to prevent respiratory distress or injury to the patient.
Quantity affected: 1,492 units (139 units US, 1,353 OUS).
Quantity affected: 455 units (310 units US, 145 OUS).
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES ยท Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.