EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect fl

FDA device recall Z-1150-2013 · posted 2013-04-18 · Terminated

Recall details

Recalling firm

Advanced Sterilization Products

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

FEB

Quantity affected

761 units

Distribution

Nationwide Distribution

Date initiated

2013-03-28

Date posted

2013-04-18

Date terminated

2013-08-22

Location

Irvine, CA

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