| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00043-1 |
| Product Name/Description |
neoBLUE blanket LED Phototherapy Systems
Device Numbers:
007301 neoBLUE blanket LED Phototherapy System with Large blanket/pad; AUS power cord
007302 neoBLUE blanket LED Phototherapy System with Small blanket/pad; AUS power cord
Serial numbers up to and including xxxx004282
ARTG Number: 97472 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
A potential issue of discolouration/degradation/melting of the fiber optic bundle at the pad connector which is inserted in the neoBLUE blanket light box has been identified. The manufacturer is in the process of confirming an updated neoBLUE blanket configuration which will not be susceptible to the degradation issue. (Please note that the date of project completion is uncertain at this time.) |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Paragon is requesting users to continue to check the fiber optic connection before use as described in the Technical Bulletin. Users are advised to refer to the Technical Bulletin for further important information and that they will be contacted for a replacement or upgrade when the updated configuration is available.
This action has been closed out on 28/02/2019 |
| Contact Information |
1300 369 559 - ParagonCare |