}

FDA clears System 83 Plus AERs for some duodenoscope reprocessing

04/24/2018

The FDA is notifying healthcare facilities that Custom Ultrasonics has completed validation testing of the System Plus Automated Endoscope Reprocessors (AERs) with specific duodenoscopes and FDA has determined that the validation data demonstrate the System 83 Plus can effectively achieve high-level disinfection of certain duodenoscopes. As a result, the System 83 Plus AERs may now be used to reprocess only the Olympus TJF-Q180V duodenoscope and the Pentax ED-3490TK duodenoscope. Please note that the System 83 Plus is not validated for the reprocessing of FUJIFILM Medical Systems, U.S.A., Inc. (Fujifilm) duodenoscopes or duodenoscopes with open elevator wire channels. Read the FDA safety alert.

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