| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00908-1 |
| Product Name/Description |
Pentax Ultrasound Video Bronchoscope
Model Number: EB-1970UK
All Serial Numbers
ARTG Number: 234953 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
Pentax Medical has become aware of an error in the description of the Instructions for Use (IFU) for a specific model of Pentax Ultrasound Video Bronchoscope relating to the reprocessing of scopes. Following the instructions in the erroneous IFU may result in ineffective reprocessing which may pose a risk of contamination and/or anaphylactic shock. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Pentax Medical is requesting customers ensure that all potential users in affected facilities are made aware of this recall action and are provided with the new Instructions For Use (IFU) supplied with the Customer Letter.
This action has been closed out on 25/05/2021 |
| Contact Information |
1300 736 829 - Pentax Medical |