EVIS EXERA and EVIS 140 Video System - Duodenovideoscope (2018-08-14)

Starting date:

August 14, 2018

Posting date:

September 7, 2018

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-67686

• 
  Reason
• 
  Affected products

Affected products

1. EVIS EXERA Video System - Duodenovideoscope 
2. EVIS 140 Video System - Duodenovideoscope

Reason

Manufacturer issuing new reprocessing procedures consisting of revised manual cleaning and high level disinfection procedures. The new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps during pre-cleaning, manual cleaning and manual disinfection.

Affected products