FDA issues safety alert on Custom Ultrasonics reprocessors

Editor's Note

The Food and Drug Administration (FDA) on August 17 issued a Safety Alert on the System 83 Plus Automated Endoscope Reprocessors by Custom Ultrasonics (Warminster, Pennsylvania), recommending that healthcare facilities stop using them to reprocess duodenoscopes.

The system may still be used for reprocessing endoscopes other than duodenoscopes.

Posted 08/17/2016] AUDIENCE: Risk Manager, Gastroenterology, Pulmonology, General Surgery ISSUE: The FDA is notifying health care facilities of Custom Ultrasonics' May 6, 2016 URGENT MEDICAL DEVICE RECALL, and advising users to stop using its System 83 Plus AERs for reprocessing of duodenoscopes.