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U.S. Department of Health and Human Services

Class 2 Device Recall EVOTECH

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 Class 2 Device Recall EVOTECH see related information
Date Posted April 18, 2013
Recall Status1 Terminated on August 22, 2013
Recall Number Z-1150-2013
Recall Event ID 64781
510(K)Number K082392 
Product Classification Accessories, cleaning, for endoscope - Product Code FEB
Product EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004.

Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
Code Information 28
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Recalling Firm/
Manufacturer
Advanced Sterilization Products
33 Technology Dr
Irvine CA 92618-2346
949-453-6400
For Additional Information Contact
949-453-6400
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Under Investigation by firm
Action An Urgent Medical Device Field Correction letter dated 3/28/13 was sent to all customers who purchased the EVOTECH Endoscope Cleaner and Reprocessor (ECR). The letter informed the customers of the problems identified and the actions to be taken. Customers are informed that the failure can potentially cause the following outcomes for the cycles listed below: 1. In the Full Reprocessing Cycle (Cleaning and HLD): there is a potential for residual rinse water and/or alcohol to remain in the endoscope channels after the cycle completes. 2. In the HLD-Only Cycle: there is potential for an adequate amount of high-level disinfectant solution to be sent through some endoscope channels. If customers observe smoke, then they are instructed to: a. Power OFF the device. b. Report your incident to ASP Professional Services at (888) 783-7723 and select option #2. c. Do not use the device until it has been serviced by ASP. Customers are instructed to return attached buyer return card acknowledging their receipt of this communication. Customers are instructed to contact Stericycle at (866) 761-9566 for any questions related to the field correction.
Quantity in Commerce 761 units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FEB and Original Applicant = ADVANCED STERILIZATION PRODUCTS
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