Draeger Medical recalls Apollo anesthesia machines (cat. 8605310) due to potential risk of delivering 100% N2O causing patient hypoxia. Affected units may need immediate action to prevent serious injury.
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 Apollo Anesthesia Machines (model 8605310) because they could deliver 100% nitrous oxide (N2O) in an emergency, risking patient hypoxia and potentially death. This is a serious safety issue that requires immediate attention from healthcare providers using the device.
The Apollo anesthesia machine may dose 100% nitrous oxide (N2O) during a fault, bypassing the safety mechanism that prevents hypoxic mixtures from reaching the patient. This could lead to severe oxygen deprivation and potentially death if the machine fails in critical situations.
Healthcare providers using the Apollo Anesthesia Machine for surgery or medical procedures are most at risk. Patients receiving anesthesia through this device could face life-threatening hypoxia if the machine malfunctions.
The recalled model is the Apollo Anesthesia Machine with catalog number 8605310. It was sold in the U.S. for use in operating rooms and medical facilities. The device is used for continuous flow anesthesia systems.
Discontinue use of the Apollo Anesthesia Machine (model 8605310) if it is in operation to prevent potential patient hypoxia.
The recall affects healthcare providers using the device. Patients are at risk if the machine malfunctions during anesthesia, but the device is designed for medical use in controlled settings.
Check if your machine has catalog number 8605310. The recall applies to units sold in the U.S. for continuous flow anesthesia systems in operating rooms.
Immediately stop using the machine and contact Draeger Medical for further instructions. The recall requires urgent action to prevent patient harm.
We’ve drafted a message you can send Draeger to request your refund or repair — edit it as you like.
Subject: Recall Z-2253-2018 — Draeger Draeger Hello, I own a Draeger that is covered by recall Z-2253-2018 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.
