Recall Z-1150-2013 ยท FEB Accessories, Cleaning, For Endoscope
Advanced Sterilization 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.
| Date | Apr 18, 2013 (initiated Mar 28, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 ade |
| Quantity | 761 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082392 | EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR Advanced Sterilization Products, Nov 13, 2008 |