Draeger recalls Fabius GS Premium anesthesia machines (cat. 8607000) due to potential risk of hypoxic patient mixtures from N2O dosing errors. This could lead to serious harm 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 is recalling its Fabius GS Premium Anesthesia Machines (model 8607000) because a fault could cause the machine to dose 100% nitrous oxide (N2O) to patients, potentially leading to hypoxia and death. This is a serious hazard that requires immediate attention from medical users.
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 that patients receive, potentially causing death due to lack of oxygen.
Healthcare professionals using the Fabius GS Premium Anesthesia Machines for surgery, anesthesia, or recovery in operating rooms. Patients undergoing procedures with these machines are at risk of hypoxia if the device malfunctions.
Check for the model number 8607000 on the machine. These machines were sold for use in operating rooms, induction, and recovery areas for anesthesia procedures.
Immediately cease using the Fabius GS Premium Anesthesia Machine (model 8607000) until a replacement is obtained.
The machine may dose 100% nitrous oxide (N2O) during a fault, which could create a hypoxic mixture for patients, potentially causing death.
Immediately stop using the machine and contact Draeger Medical for a replacement or repair.
No, the machine poses a risk of patient hypoxia and death if it malfunctions, so it should not be used until the recall is addressed.
We’ve drafted a message you can send Draeger to request your refund or repair — edit it as you like.
Subject: Recall Z-2250-2018 — Draeger Draeger Hello, I own a Draeger that is covered by recall Z-2250-2018 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.
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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.
