| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00924-1 |
| Product Name/Description |
Spectra Optia Apheresis System
All Serial Numbers
ARTG number: 130529 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/09/2012 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has become aware that the Spectra Optia System's Return Line Air Detector (RLAD) can potentially fail as a result in a non-continuable alarm condition. If air has been falsely detected due to a defective RLAD during a procedure, a continuous "Air detected in Return Line" alarm will occur and will not allow the procedure to continue. If the RLAD experiences a defect during prime, the system will generate a "Return Line Air Detector failed fluid check" alarm and will not allow the procedure to be performed until serviced. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Terumo BCT is providing work around instructions for users to follow. |
| Contact Information |
1300 553 507 - Terumo BCT Office |