| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00466-1 |
| Product Name/Description |
neoBLUE LED Phototherapy Lights (2nd Generation)
ARTG Number: 97472 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
The neoBLUE 2 systems were manufactured using individual LEDs of higher intensity output than the original product specification. To compensate for this higher intensity, customers were previously advised to increase the distance between the phototherapy light and the patient. The neoBLUE 2 light is now being recalled and replaced with the current generation light. |
| Recall Action |
Recall |
| Recall Action Instructions |
Paragon Care is requesting customers identify if they have affected stock by checking for a black band around the light enclosure base. If so, users are requested to record the Serial number (located on the back panel of the light enclosure) on the reply form and return the completed form in order to receive a free replacement. Users are then advised to place the affected light in the box which contained the replacement prior to its return to Paragon Care.
This action has been closed out on 14/11/2018 |
| Contact Information |
1300 369 559 - Paragon Care |