| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00906-1 |
| Product Name/Description |
Ultrasound Upper GI Video Scopes
Model Numbers: EG-3870UTK and EG-3670URK
ARTG Number: 234939 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
Pentax Medical has become aware of an error within the Instructions For Use for specific models of Ultrasound Upper GI Video Scopes.
On page 70 the IFU currently reads "The cleaning detergent solution should remain in contact..." and the correct text is "The disinfecting solution must remain in contact..."
To date, no incidents have been reported to Pentax Medical in relation to this error. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Pentax Medical will be providing an updated Instructions For Use (IFU) to affected customers.
This action has been closed out on 14/04/2021 |
| Contact Information |
1300 736 829 - Pentax Medical Australia Customer Service |