Series 400 Electronic Video Endoscope System - Duodenoscope (2019-01-24)

Starting date:

January 24, 2019

Posting date:

February 22, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69106

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  Reason
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  Affected products

Affected Products

Series 400 Electronic Video Endoscope System - Duodenoscope

Reason

FUJIFILM announced a voluntary Recall/FSCA for the ED-530XT duodenoscope includes replacement of the forceps elevator mechanism and O-Ring seal, replacement of the distal end cap, and a new Operation Manual. The updated design and the revision of the Operation Manual were implemented in an abundance of caution to help reduce the potential risk to health that may be associated with inadequate reprocessing of the device.

Affected products