FDA-Device2013-04-24Class II

EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.

Advanced Sterilization Products
Hazard

Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because they have received reports of smoke emanating from the system due to a circuit board malfunction that may occur in the Channel Control Manifold sub-assembly.

Sold states
Nationwide Distribution
Affected count
761 units
Manufactured in
33 Technology Dr, N/A, Irvine, CA, United States
Products
EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1150-2013

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