Health Canada — Medical Devices · Canada · 2013-10-17 · Type III
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Reported risk: 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.
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