Draeger Medical recalls Fabius GS Tiro anesthesia machines (cat. 8606000) due to potential risk of hypoxic patient mixtures from faulty N2O dosing. This could lead to serious injury or death during surgery.
The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.
Draeger Medical is recalling its Fabius GS Tiro anesthesia machines because a fault in the device could allow 100% nitrous oxide to be dosed to patients, potentially causing hypoxia and death. This is a serious safety issue that requires immediate attention.
The machine's S-ORC module may fail to prevent setting a 100% nitrous oxide flow rate during a fault. This could create a hypoxic mixture for the patient, leading to potential death if the machine is used without proper monitoring.
Healthcare professionals using the Fabius GS Tiro anesthesia machine (model 8606000) in operating rooms are most at risk. Patients undergoing anesthesia could face serious injury or death if the machine malfunctions.
Check for the model number 8606000 on the Fabius GS Tiro anesthesia machine. These machines are used in operating rooms for inhalation anesthesia and may be sold with medical gas pipelines or external gas cylinders.
Immediately stop using the Fabius GS Tiro anesthesia machine (model 8606000) if it is in operation.
The recalled model is 8606000.
Yes, the recall states that a fault could result in a hypoxic mixture being dosed to the patient, potentially causing death.
The recall record does not mention any remedy or fix.
We’ve drafted a message you can send Draeger to request your refund or repair — edit it as you like.
Subject: Recall Z-2251-2018 — Draeger Draeger Hello, I own a Draeger that is covered by recall Z-2251-2018 from Draeger. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
