Draeger Medical’s Fabius Series Anesthesia Machines have been recalled because they may fail to provide automatic ventilation. The Fabius GS Premium, Fabius OS, Fabius Tiro, and Fabius Tiro D-M anesthesia machines are all subject to the recall. These anesthesia machines are used to administer anesthesia and ventilation to patients during surgical procedures.
The minimum specified clearance between an electrical component and the unit housing was not maintained for some devices. As a result, bypass current flowing in the interior of the unit may cause the automatic ventilation function of the device to fail.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe