Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1150-2013 — EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.

U.S. FDA — Device Enforcement · United States · 2013-03-28 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1150-2013
Date of alert
2013-03-28
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Advanced Sterilization Products
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
5041090177
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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