| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01215-2 |
| Product Name/Description |
Auriga XL 4007 Laser System
Material Number (UPN): M0068FS4007G0
Serial Numbers: 20546219 and 20575518
ARTG Number: 287772 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/09/2017 |
| Responsible Entity |
|
| Reason/Issue |
Boston Scientific has identified certain Auriga XL 4007 Laser System Consoles which may have an incorrectly assembled trigger wire. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in error codes or failure to start the console. Should the console fail to start, the most common consequence would be a delay of the procedure while the affected console is swapped for another. If a substitute console or immediate alternative treatment is not available, this issue may result in moderate risk to the patient related to repeat anaesthesia for the re-intervention at a later date. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
1. Users are to stop using the affected goods and complete and return the supplied correction form to indicate receipt of the letter.
2. Boston Scientific certified engineers will begin contacting customers to schedule correction of affected consoles within two weeks of this communication.
This action has been closed out on 25/09/2018 |
| Contact Information |
02 8063 8299 - Boston Scientific Technical Services |