| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00886-1 |
| Product Name/Description |
Spectra Optia Apheresis System - Return Line Air Detector (RLAD)
ARTG Number: 130529 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/08/2014 |
| Responsible Entity |
|
| Reason/Issue |
Terumo BCT has redesigned the Return Line Air Detector (RLAD) component of the Spectra Optia Apheresis System. This redesign will further reduce the low occurrence of false air detections during a procedure; the plan has been to install the replacement component on devices in which a RLAD false air detect has occurred. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Terumo BCT is replacing the existing RLAD sensor with the redesigned component on all Spectra Optia systems in Australia. If false air detections have occurred on a system in the last 12 months the upgrade will be scheduled as soon as possible. Where no issues have been reported the RLAD sensor will be replaced during the next scheduled preventative maintenance visit. This action has been closed-out on 03/05/2016. |
| Contact Information |
02 9429 3600 - Terumo BCT |