(b)(4).On november 30,2015, fsca 2015-11-30 was issued regarding revised decontamination procedures for heater and heater-cooler systems from maquet.This fsca was put on hold a few days later with fsca 2015-12-10.A new fsca will be issued as soon as the new disinfection procedure is properly validated and can be launched.The new ifu is currently under revision and will contain the instructions for the new disinfection procedure.December 2016 is the anticipated market launch of the new disinfection procedure.A supplemental medwatch will be submitted if additional informations becomes available.
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