Fujifilm Scope Systems (2016-04-08)

Starting date:

April 8, 2016

Posting date:

April 29, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-58122

• Reason
• Affected products

Affected Products

A. DOUBLE BALLOON METHOD ELECTRONIC ENTEROSCOPY SYSTEM - ENTEROSCOPE
B. GASTROSCOPE EG
C. COLONOSCOPE EC
D. BRONCHOSCOPE
E. SERIES 200 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - COLONOSCOPE
F. SERIES 200 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - GASTROSCOPE
G. SERIES 200 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - SIGMOIDOSCOPE
H. SERIES 400 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - COLONOSCOPE
I. SERIES 400 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - BRONCHOSCOPE
J. SERIES 400 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - DUODENOSCOPE
K. SERIES 400 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - GASTROSCOPE
L. SERIES 400 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - SIGMOIDOSCOPE
M. SIGMOIDSCOPE
N. ULTRASONIC ENDOSCOPE
O. ULTRASONIC BRONCHOSCOPE
P. ENDOSCOPE (UPPER GI TRACT)
Q. ENDOSCOPE (LOWER GI TRACT)

Reason

Changes to the instructions for the leak test method specified for all Fujifilm endoscopes in the cleaning, disinfection and storage operation manuals as well as the operation manuals for the air leak tester, LT-7F, were made to ensure consistency with the ISO 8600-7 standard. Specific requirements added were to conduct the submersion test for the duration of at least one minute and using a water temperature range of 10 degrees celsius to 40 degrees celsius.

Affected products