| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00897-1 |
| Product Name/Description |
GIF-1TH190 Gastrointestinal Videoscope
Serial number range: Before 2446103 or After 2500453
ARTG 355250
(Olympus Australia Pty Ltd - Gastroduodenoscope, flexible, video) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/10/2024 |
| Responsible Entity |
|
| Reason/Issue |
The current Instructions for Use (IFU) addendum is deemed ineffective in ensuring the drying procedure instructions provide sufficient endoscope channel drying directions. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to implement use of the Addendum stating that the channel drying time has been extended by 12 minutes to purge alcohol from the channels. This is accomplished by drying each channel for 3 minutes, in the sequence described in the addendum. Customers should ensure all reprocessing personnel are completely knowledgeable and thoroughly trained on the new alcohol purge requirements. |
| Contact Information |
1300 132 992 - Olympus Customer Operations |