Here’s what you should know.
1. The approval is for System 83 Plus AERs, including System 83 Plus, System 83 Plus 2 and System 83 Plus 9 AERS. The reprocessor can be used to process the Olympus TJF-Q180V duodenoscope and Pentax ED-3490TK duodenoscope.
2. The system is not approved to reprocess Fujifilm Medical System duodenoscopes or duodenoscopes with open elevator wire channels.
3. The FDA conducted several tests of the reprocessor, finding it effectively disinfected both the Olympus TJF-180V duodenoscope and the Pentax ED-3490TK duodenoscope.
4. In 2012, the FDA ordered Custom Ultrasonics to cease manufacturing and distributing of System 83 because of repeated violations of the quality system. The recall was expanded in November 2015 because the reprocessors were found to be in violation of the FD&C act.
5. The FDA will continue to work with the company to ensure the scopes remain in compliance with the FD&C act.
To read the full text of the release, click here.
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