Health product recall

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

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

Series 400 Electronic Video Endoscope System - Duodenoscope

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • ED-530XT
Companies
Manufacturer

Fujifilm Corporation

26-30 NISHIAZABU, 2 CHOME MINATO-KU

TOKYO-TO

JAPAN