Reliance Endoscope Processor (2013-09-12)

Starting date:

September 12, 2013

Posting date:

October 17, 2013

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-36235

• Reason
• Affected products

Recalled products

Reliance Endoscope Processor 

Reason

The Reliance Endoscope Processing system (REPS) is intended for washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant, semi-critical devices such as GI flexible endoscopes, bronchoscopes and their accessories. Steris corporation is providing an urgent product safety notice to inform affected customers of an important change in the reliance endoscope processing system instructions for use when processing fujinon G5 and G8 type flexible GI Endoscopes. This notice excludes fujinon model EC-530H l and EC-530LS GI Endoscopes, and does not affect use of the Reliance EPS to process any other manufacturer's qualified endoscopes.

Affected products