| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00319-1 |
| Product Name/Description |
EVOTECH Endoscope Cleaner and Reprocessor (ECR) System (Endoscope disinfecting unit)
Product number: 50004
ARTG: 146438 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
Johnson & Johnson Medical is issuing a product correction for the EVOTECH Endoscope Cleaner and Reprocessor system after receiving reports of smoke emanating from the system and upon further investigation has discovered that a circuit board malfunction may occur in the Channel Control Manifold sub-assembly. This failure can potentially cause the following outcomes for the cycles:
1. Full Reprocessing Cycle (Cleaning and HLD) - If this issue were to occur while running a full automated cleaning and high level disinfection (HLD) cycle, there is potential for residual rinse water and/or alcohol to remain in the endoscope channels after the cycle completes,
2. HLD-Only Cycle - If this issue were to occur during reprocessing of endoscopes qualified for the HLD only cycle, there is potential for an inadequate amount of high-level disinfectant solution to be sent through some endoscope channels. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Johnson & Johnson Medical Pty Ltd is providing the users with the instructions to prevent the issues from occurring. |
| Contact Information |
1800 252 194 - Johnson and Johnson Medical Customer Service |