Summary of Problem and Scope
FUJIFILM Medical Systems, U.S.A, Inc. is removing certain legacy duodenoscope models (ED-250XLS, ED-250XTS, ED-450XLS, and ED-450XTS) from clinical use due to the limited number currently in use.
The company will replace these models with the ED-530XT model, along with necessary accessories, at no cost.
Recommendations for Health Care Facilities and Staff
Remove and return the legacy duodenoscope models to FUJIFILM Medical Systems, U.S.A, Inc.
Train staff on the validated reprocessing instructions for the ED-530XT model and implement them as soon as possible.
Immediately remove from service any duodenoscope that shows signs of damage.
Manual:
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