Draeger Medical recalls Fabius Tiro M anesthesia machines (catalog 8608400) due to risk of ventilation failure if motor position detection is disturbed. Affected units may have damaged ventilator covers.
The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.
Draeger Medical is recalling Fabius Tiro M anesthesia machines because they can fail to ventilate if the motor position sensor is disturbed or the ventilator cover is damaged. This could lead to inadequate breathing support during surgery.
The machine's automatic ventilation system may stop working if the motor position sensor is disturbed. If the ventilator cover is damaged, manual ventilation could also fail, potentially causing breathing problems during surgery.
Healthcare professionals using the Fabius Tiro M anesthesia machines in operating rooms are most at risk. Patients receiving anesthesia during surgery could be affected if the machine fails.
Check for the product catalog number 8608400 on the machine. The affected units were sold with serial numbers starting with ASKK-0001.
Inspect the ventilator cover for damage and ensure the motor position sensor is not disturbed.
The automatic ventilation may fail if the motor position detection is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.
The recall does not specify a remedy, so check with Draeger Medical for guidance.
The recall states that ventilation failure could occur, but it does not specify a risk of serious injury in normal use.
We’ve drafted a message you can send Draeger Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1484-2018 — Draeger Medical Draeger Medical Hello, I own a Draeger Medical that is covered by recall Z-1484-2018 from Draeger Medical. 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.