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FDA Issues Class 1 Recall of GE Anesthesia System

by Brendon Nafziger, DOTmed News Associate Editor | May 14, 2010
Get details on the GE recall
GE Healthcare, LLC recalled anesthesia systems because a wiring harness defect could cause the machines to unexpectedly shut down, the U.S. Food and Drug Administration announced on Thursday.

The recall affects specific lots of Waukesha, Wisc.-based GE's Aisys and Avance Anesthesia Systems distributed between Oct 9, and Oct 29, 2009, the FDA said.

The agency considers the recall its most serious type, Class 1, because the defect could cause serious injury or loss of life.

The machines provide inhaled anesthesia and ventilation support. Shutting down during a procedure would stop delivery of anesthetic drugs, patient monitoring or ventilation, the FDA said.

On March 12, GE Healthcare warned customers with a letter about the possible safety hazard, the FDA said.

The FDA has a full list of model and lot numbers involved here: http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm211877.htm.