Draeger Medical recalls Fabius GS MRI anesthesia machines due to potential risk of hypoxic patient mixtures from N2O dosing errors. This could lead to patient death if a fault occurs in the S-ORC module.
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 MRI Anesthesia Machines because a fault in the S-ORC module could allow 100% N2O to be dosed to patients, risking hypoxia and potentially death. Patients using these machines should stop using them immediately until a remedy is provided.
The S-ORC module in the machine may fail to prevent the device from dosing 100% nitrous oxide (N2O) to patients during a fault. This could create a hypoxic mixture that leads to patient death if the machine malfunctions.
Healthcare professionals using the Fabius GS MRI Anesthesia Machines for inhalation anesthesia in operating rooms are most at risk. Patients receiving anesthesia through these machines could face serious harm or death.
The recalled product is the Fabius GS MRI Anesthesia Machine with catalog number 8607300. It is used in operating rooms for inhalation anesthesia and can be used with medical gas pipelines or external gas cylinders.
Immediately stop using the Fabius GS MRI Anesthesia Machine with catalog number 8607300 if it is in your possession.
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 could result in a hypoxic mixture being dosed to the patient, potentially causing death.
The recall record does not specify a remedy or fix for this issue.
You should stop using the Fabius GS MRI Anesthesia Machine with catalog number 8607300 immediately until a remedy is provided.
We’ve drafted a message you can send Draeger to request your refund or repair — edit it as you like.
Subject: Recall Z-2252-2018 — Draeger Draeger Hello, I own a Draeger that is covered by recall Z-2252-2018 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.
