| TGA Action ID |
RC-2025-RN-00520-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Gastrointestinal Videoscope GIF-EZ1500 and Colonovideoscopes CF-EZ1500DI and CF-EZ1500DL
GIF-EZ1500 EDOF GASTROSCOPE
Material Number: N6129031
CF-EZ1500DI COLONOSCOPE
Material Numbers: N6022431, N6022531
All Serial Numbers
ARTG's: 112270 & 121183 |
| ARTG Number |
112270, 121183 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Olympus is updating the Instructions for Use for the Gastrointestinal Videoscope GIF-EZ1500 and Colonovideoscopes CF-EZ1500DI and CF-EZ1500DL.
The update will include more detailed guidance on identifying signs of degradation resulting from repeated reprocessing of the products noted above. |
| Instructions for Customers/Users |
Customers may continue to use the device as per the customer letter and the amended Instructions for Use.
The appendices sent with the letter provide the comparison and highlights minor changes in the Reprocessing and Operating Manuals.
The letter will also contain links to the e-IFU.
NB: The IFU are still being reviewed by the TGA, and further updates may be forthcoming via updates to this action.
This action has been closed out on 31/07/2026 |
| Action Commencement Date |
10/06/2025 |
| Responsible Entity |
|
| Contact Information |
1300 132 992 - Olympus Customer Operations |