| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00819-3 |
| Product Name/Description |
Pentax PTX-EG-387UTK Ultrasound Video Gastroscope (flexible gastroduodenoscope)
ARTG Number: 194533 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
Pentax has been notified of a potential risk related to the use of the EG-3870UTK Ultrasound Video Gastroscope in combination with aspiration needles if the Instructions For Use is not followed carefully by the user. Specifically, if the user fails to properly position the elevator while advancing the aspiration needle through the endoscope, the needle could disengage from the elevator. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are being provided with revised instructions for use (IFU) which should be read and followed by the users of the equipment. The owners manual is to be updated with the addendum that has been provided by the Sponsor. |
| Contact Information |
1800 429 551 - Device Technologies |