Aisys and Avance Anesthesia System Recall: Control Board Defect
A Class 1 medical device recall has been issued for GE Healthcare Aisys and Avance Anesthesia Systems, which can fail to provide ventilation for patients under the affects of anesthetics.
The anesthesia system recall was announced by FDA on May 10 and given a class 1 status after GE Healthcare officials sent an “Urgent Medical Device Correction” letter in March to the management at hospitals which had bought the machines. The FDA reports that the recalled machines have a defective control board wiring harness, which can cause the machine to shut down unexpectedly, resulting in loss of ventilation for the patient, anesthetic delivery and patient monitoring.
The FDA did not say whether there had been any injuries or deaths associated with the recall. A Class 1 designation is the most severe classification for a medical device recall, and means that the FDA believes that there is a reasonable probability that using the defective product could result in serious injury or death.
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The affected machines include 18 Avance Anesthesia Machine and Monitor systems, product number 1009-9002-000. Four of the machines were sold in the U.S. and 14 were sold to other countries. The recall also includes 15 Aisys Anesthesia Machine and Monitor systems, product number 1011-90000-000, all sold outside the U.S.
The serial numbers of every machine affected are listed on FDA’s recall notice.
The FDA requests that anyone who experienced adverse events while using these products or under the effects of one of these products contact the FDA’s MedWatch Program at www.fda.gov/medwatch.
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