Safety Communications UPDATE
The FDA has notified health care facilities that Custom Ultrasonics has completed validation testing of the System 83 Plus AERs with specific duodenoscopes.
The System 83 Plus AERs may now be used to reprocess only the Olympus TJF-Q180V duodenoscope and the Pentax ED-3490TK duodenoscope.
Background
In 2007, Custom Ultrasonics entered into a Consent Decree with FDA due to repeated violations of the Quality System Regulation.
In 2012, the FDA ordered Custom Ultrasonics to cease manufacturing and distributing the System 83 Plus Washer/Disinfector.
Multiple recalls and safety communications were issued between 2015 and 2017 due to Custom Ultrasonics’ violations of the FD&C Act and applicable regulations.
As of April 10, 2018, the FDA has determined that Custom Ultrasonics’ System 83 Plus AERs validation is adequate for certain duodenoscopes.
Manual:
Download: Custom Ultrasonics’ System 83 Plus Automated Endoscope Reprocessors (AERs) User Manual
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