| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01344-1 |
| Product Name/Description |
EVOTECH Endoscope Cleaner and Reprocessor (ECR)
Part Number: 50004
ARTG Number: 146438 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/12/2013 |
| Responsible Entity |
|
| Reason/Issue |
The Pentax EG-3670URK flexible endoscope has been qualified for use with the EVOTECH ECR, however it cannot currently be processed in the EVOTECH ECR due to incorrect flow rate parameter programming in the system that is specific to this endoscope. The minimum flow rate has been programmed at levels higher than those required for effective cleaning of this scope which leads to cycle cancellation for error of Low Flow. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Johnson & Johnson Medical is advising users with the Pentax EG-3670URK scope to manually clean and undertake a high level of disinfection prior to use. The EVOTECH ECR can continue to be used in accordance with the user guide for all other endoscopes that have been qualified and validated. A software update will be implemented as a permanent fix. |
| Contact Information |
1800 252 194 - Customer Service |