GE Aisys and Avance anesthesia systems Recall announced

GE Healthcare and the Food and Drug Administration (FDA) have notified healthcare professionals of a Class I recall of certain lots of the Aisys and Avance Anesthesia Systems. The control board wiring harnesses have a defect which can cause the machines to unexpectedly shut down, terminating ventilation, anesthetic delivery and potentially patient monitoring.

Healthcare professionals are encouraged to report adverse events related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Online: www.fda.gov/MedWatch/report.htm1
  • Phone: 1-800-332-1088
  • Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch Download Forms2 page, to address on the pre-addressed form
  • Fax: 1-800-FDA-0178

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