| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01213-1 |
| Product Name/Description |
Auriga XL 4007 Laser System
Material Number (UPN): M00684007GO
Serial Numbers: 4007-A-076 and 4007-A-078
ARTG Number: 287772 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/09/2017 |
| Responsible Entity |
|
| Reason/Issue |
Boston Scientific has identified specific Auriga XL 4007 Laser Consoles have been produced with the incorrect laser warning label applied to the console. The labels on the affected consoles provide incorrect information regarding the maximum power (P) and the wavelength (?) actually emitted by the console. The two potentially impacted elements related to the laser warning label being incorrect are: the selection/ordering of laser protection goggles and the arrangement or ‘setup' of the laser use area. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A Boston Scientific Certified Field Service Engineer (FSE) will replace the console’s Laser Warning Label with the correct Label. Users are advised to continue to follow the use and room setup instructions per Auriga XL User Manual (91043397). No further action is required by the users prior to the FSE visit.
This action was closed on the 25/09/2018. |
| Contact Information |
02 8063 8299 - Boston Scientific Technical Services |