FUJIFILM Medical Systems, U.S.A, Inc. Removes Certain Older Duodenoscope Models from Clinical Use: FDA Safety Communication

Summary of Problem and Scope

FUJIFILM Medical Systems, U.S.A, Inc. is removing certain older duodenoscope models (ED-250XLS, ED-250XTS, ED-450XLS, and ED-450XTS) from clinical use due to their 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

Health care facilities should remove the older duodenoscope models from circulation and return them to FUJIFILM, train staff on the validated reprocessing instructions for the ED-530XT model, and implement these procedures as soon as possible.

Facilities should also immediately remove from service any duodenoscope that shows signs of damage.

Manual:

Download: FUJIFILM Medical Systems, U.S.A, Inc. Removes Certain Older Duodenoscope Models from Clinical Use: FDA Safety Communication

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